CClinicalTrials.gg
CompletedNCT05176860Updated Aug 26, 2026Results posted

Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy

An interventional study of CBCT Imaging in Lung Cancer, Liver Cancer and Breast Cancer, sponsored by Varian, a Siemens Healthineers Company. Completed at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Varian, a Siemens Healthineers Company · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.

Read the detailed description

This study focuses on potential benefits of a high performance cone beam CT (CBCT) image guidance system for improved precision in the delivery of radiotherapy. CBCT is currently used during radiation therapy to align the patient to their original treatment plan to increase the precision of radiation delivery. Current CBCT imaging technology requires approximately a minute to acquire an image. In order to acquire images with sufficient quality to allow accurate targeting, the patient may need to perform multiple breath hold maneuvers to "freeze" the motion of tumors that move with the breathing cycle (e.g. lung, liver, and breast tumors). The new high-performance CBCT can acquire an image in approximately 6 seconds, potentially enabling acquisition of images with a single breath hold. Improved motion compensation algorithms used in image reconstruction may allow acquisition of good quality images even while a patient is not holding their breath.

The methodology for the subject's treatment setup, CT simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team and is not specified by this study. Enrollment in the study may occur after treatment delivery has started but must be prior to the fifth fraction.

Following completion of informed consent to participate in this study, high-performance CBCT imaging will be scheduled immediately before or after one of the subject's first five scheduled radiation treatment fractions. Two research CBCT images will be acquired, one with breath hold, the other with free breathing.

With minimal disruption for participating patients, this study will enable a comparison of (i) the subject's treatment planning fan-beam CT and (ii) the conventional CBCT acquired on an existing treatment unit with (iii) the high-performance CBCT. Image quality of the high performance CBCT image data will thereby be compared to both a best-case standard (fan-beam) and the status-quo for on-couch imaging to isolate and identify improvements.

02

Conditions studied

  • Lung Cancer
  • Liver Cancer
  • Breast Cancer
  • Other Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 31 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Varian, a Siemens Healthineers Company is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject is scheduled for treatment on one of the five TrueBeam platforms at the NS Health QE2 site.
  • Subject is receiving radiation therapy using a breath-hold technique (for example, lung, liver and left breast cancers).

Exclusion criteria

Exclusion Criteria:

  • Patient is pregnant or has plans for pregnancy during the period of treatment.
  • Patient is unwilling to consent to participating to the study, or for whom informed consent is not possible.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    High-performance CBCT imaging

    Two additional study imaging sets are acquired.

    Device: CBCT Imaging

Interventions

  • DeviceCBCT Imaging

    Two research CBCT images will be acquired per subject.

06

What researchers measure

Primary outcomes

  1. CBCT Image Quality - Artifact Index

    Artifact Index (AI) is a measurement of the strength of imaging artifact and the degree to which is affects visibility of anatomical structures in the vicinity of the artifact. Artifacts can be produced in CT and CBCT images by a number of factors, such as metal implants, gas, or breathing motion. AI = sqrt((STD\_VOI)\^2 - (STD\_background)\^2), where STD\_VOI is the standard deviation of the image Hounsfield Units in a region of interest at the location of an artifact, and STD\_background is the standard deviation of the Hounsfield Unit values in the background (i.e. in similar tissue but away from the artifact. A lower AI value indicates that the artifact has a lower impact on image quality. Artifacts were identified in all study participants. The median AI across the study population is presented for four imaging modalities.

    Time frame: 1 day

  2. CBCT Image Quality - Image Nonuniformity

    Nonuniformity (NU) is a measure of the variation of CT image intensity in uniform tissue. NU = (HU\_max - HU\_min)/(HU\_max + HU\_min), where HU\_max and HU\_min are the maximum and minimum Hounsfield Unit values among multiple locations sampled within regions of uniform tissue that were relevant to the anatomy of interest (e.g., a uniform region of breast tissue for patients undergoing breast treatments). A lower NU represents greater uniformity of CT image intensity within a region of interest. Median NU across the study population is presented for four imaging modalities.

    Time frame: 1 day

  3. CBCT Image Quality - Contrast

    Contrast represents the ability to distinguish between two different regions in a CT image (e.g. to distinguish between two adjacent organs). Contrast = \|HU1 - HU2\| where HU1 and HU2 are the mean HU values in two different 100 mm\^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments). Higher contrast values indicate that it is easier to distinguish between regions (anatomical structures) in a CT image. Median contrast across the study population is presented for four imaging modalities.

    Time frame: 1 week

  4. CBCT Image Quality - Contrast to Noise Ratio

    Contrast to Noise Ratio (CNR) measures the ability to distinguish an object or lesion from its background. CNR = \|HU1 - HU2\|/\[0.5 (STD1 + STD2)\] where HU1 and HU2 are the mean Hounsfield Unit values in two different 100 mm\^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments), and STD1 and STD2 are the standard deviations of the HU values in those same ROIs. A higher CNR makes it easier to distinguish an object from its background. CNR analysis was limited to images with similar imaging dose. Median CNR across all study participants treated for lung cancer are presented for three CBCT modalities.

    Time frame: 1 week

  5. CBCT Image Quality - HU Similarity to CT Simulation

    The intensity of a pixel in a CT image is a function of its Hounsfield Unit (HU) value. HU is also directly related to the underlying electron density, which means that the pixel value of a CT image can be used directly in the calculation of dose for a prescribed radiation treatment plan. CT simulation scanners produce images with high HU accuracy and are regularly used for radiation treatment planning. Here, we present the difference in HU between CT simulation images and different CBCT images. ΔHU = HU\_CBCT - HU\_CTSim, where HU\_CBCT and HU\_CTSim are mean values among HU averages at 4 reference points in a CBCT image and the corresponding CT simulation image, respectively. The lower the ΔHU, the greater the HU accuracy of the CBCT image, and the greater the likelihood that CBCT imaging can be used for radiation treatment planning. Median ΔHU across the study population are presented for three different tissue types for three CBCT imaging modalities.

    Time frame: 1 week

Secondary outcomes

  1. Dosimetry Calculations - Gamma Pass Rate

    Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. The overall difference between calculated radiation distributions was evaluated using three different gamma pass criteria: 3% dose difference / 3 mm distance to agreement, 2%/2mm, and 1%/1mm. The gamma pass rate is expressed as a percentage of data points that meet the pass criteria. A gamma pass rate of \> 95% is typically considered acceptable for 3%/3mm. As the gamma pass criteria become stricter, the pass rates decrease. Gamma pass rates were calculated to compare the CT simulation-based dose calculation and the high performance CBCT-based dose calculation. Gamma pass rates were also calculated to compare the CT simulation-based dose calculation and the conventional CBCT-based dose calculation. The median gamma pass rates across the entire study population are presented.

    Time frame: 1 day

  2. Dosimetry Calculations - Target DVH Volume Metrics

    Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH metrics, such as V90(%) (the percentage of the structure volume receiving 90% of the prescribed radiation dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.

    Time frame: 1 day

  3. Dosimetry Calculations - Target DVH Dose Metrics

    Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH dose metrics, such as D95(%) (the minimum dose covering 95% of the structure, expressed as a % of the prescription dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.

    Time frame: 1 day

  4. Dosimetry Calculations - Breast OAR DVH Metrics

    Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for breast cancer are the heart, ipsilateral lung, and contralateral breast. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for breast cancer are presented.

    Time frame: 1 day

  5. Dosimetry Calculations - Lung OAR DVH Metrics

    Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for lung cancer are the heart, esophagus and spinal cord. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for lung cancer are presented.

    Time frame: 1 day

  6. Dosimetry Calculations - Abdomen OAR DVH Metrics

    Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for abdominal cancer are the heart, bowel and kidneys. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for abdominal cancer are presented.

    Time frame: 1 day

  7. Patient Experience - General Ease of Breath Hold

    Study participants were asked to respond to the statement, "I find it easy to hold my breath", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

    Time frame: 1 Day

  8. Patient Experience - Ease of Breath Hold on TrueBeam

    Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds that were needed for imaging on the TrueBeam radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

    Time frame: 1 Day

  9. Patient Experience - Ease of Breath Hold on Ethos

    Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds needed for imaging on the Ethos radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

    Time frame: 1 Day

  10. Patient Experience - Relative Ease of Breath Hold Between Machines

    Study participants were asked to respond to the statement, "It was easier for me to perform the breath holds needed for imaging on one radiation machine compared to the other", on a 5-point scale, where 1 represents "TrueBeam much easier", 3 represents "Both machines equally easy", and 5 represents "Ethos much easier".

    Time frame: 1 Day

  11. Patient Experience - Overall TrueBeam Experience

    Study participants were asked to respond to the statement, "My overall experience during imaging on the TrueBeam was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

    Time frame: 1 Day

  12. Patient Experience - Overall Ethos Experience

    Study participants were asked to respond to the statement, "My overall experience during imaging on the Ethos platform was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

    Time frame: 1 Day

07

Results

Posted May 6, 2026

Participant flow

Participant flow — Overall Study
MilestoneHigh-performance CBCT Imaging
Started31
Completed30
Not completed1
Withdrew: Physician decision1

Outcome measures

PrimaryCBCT Image Quality - Artifact Index

Artifact Index (AI) is a measurement of the strength of imaging artifact and the degree to which is affects visibility of anatomical structures in the vicinity of the artifact. Artifacts can be produced in CT and CBCT images by a number of factors, such as metal implants, gas, or breathing motion. AI = sqrt((STD\_VOI)\^2 - (STD\_background)\^2), where STD\_VOI is the standard deviation of the image Hounsfield Units in a region of interest at the location of an artifact, and STD\_background is the standard deviation of the Hounsfield Unit values in the background (i.e. in similar tissue but away from the artifact. A lower AI value indicates that the artifact has a lower impact on image quality. Artifacts were identified in all study participants. The median AI across the study population is presented for four imaging modalities.

Time frame:
1 day
Reported as:
Median · HU
CBCT Image Quality - Artifact Index
HUBreath Hold High Performance CBCTFree Breathing High Performance CBCTConventional CBCTCT Simulation
CBCT Image Quality - Artifact Index20.2 (13.9 to 31.0)32.9 (14.7 to 50.2)59.2 (30.5 to 89.4)17.3 (8.2 to 24.3)
PrimaryCBCT Image Quality - Image Nonuniformity

Nonuniformity (NU) is a measure of the variation of CT image intensity in uniform tissue. NU = (HU\_max - HU\_min)/(HU\_max + HU\_min), where HU\_max and HU\_min are the maximum and minimum Hounsfield Unit values among multiple locations sampled within regions of uniform tissue that were relevant to the anatomy of interest (e.g., a uniform region of breast tissue for patients undergoing breast treatments). A lower NU represents greater uniformity of CT image intensity within a region of interest. Median NU across the study population is presented for four imaging modalities.

Time frame:
1 day
Reported as:
Median · ratio
CBCT Image Quality - Image Nonuniformity
ratioBreath Hold High Performance CBCTFree Breathing High Performance CBCTConventional CBCTCT Simulation
CBCT Image Quality - Image Nonuniformity0.1 (0.07 to 0.19)0.25 (0.15 to 0.40)0.25 (0.16 to 0.51)0.05 (0.03 to 0.09)
PrimaryCBCT Image Quality - Contrast

Contrast represents the ability to distinguish between two different regions in a CT image (e.g. to distinguish between two adjacent organs). Contrast = \|HU1 - HU2\| where HU1 and HU2 are the mean HU values in two different 100 mm\^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments). Higher contrast values indicate that it is easier to distinguish between regions (anatomical structures) in a CT image. Median contrast across the study population is presented for four imaging modalities.

Time frame:
1 week
Reported as:
Median · HU
CBCT Image Quality - Contrast
HUBreath Hold High Performance CBCTFree Breathing High Performance CBCTConventional CBCTCT Simulation
CBCT Image Quality - Contrast134.1 (119.0 to 145.9)129.7 (109.2 to 138.0)126.8 (101.8 to 151.1)142.3 (133.7 to 154.6)
PrimaryCBCT Image Quality - Contrast to Noise Ratio

Contrast to Noise Ratio (CNR) measures the ability to distinguish an object or lesion from its background. CNR = \|HU1 - HU2\|/\[0.5 (STD1 + STD2)\] where HU1 and HU2 are the mean Hounsfield Unit values in two different 100 mm\^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments), and STD1 and STD2 are the standard deviations of the HU values in those same ROIs. A higher CNR makes it easier to distinguish an object from its background. CNR analysis was limited to images with similar imaging dose. Median CNR across all study participants treated for lung cancer are presented for three CBCT modalities.

Time frame:
1 week
Reported as:
Median · ratio
CBCT Image Quality - Contrast to Noise Ratio
ratioBreath Hold High Performance CBCTFree Breathing High Performance CBCTConventional CBCT
CBCT Image Quality - Contrast to Noise Ratio6.64 (2.99 to 9.37)4.13 (3.31 to 5.41)5.10 (2.44 to 6.99)
PrimaryCBCT Image Quality - HU Similarity to CT Simulation

The intensity of a pixel in a CT image is a function of its Hounsfield Unit (HU) value. HU is also directly related to the underlying electron density, which means that the pixel value of a CT image can be used directly in the calculation of dose for a prescribed radiation treatment plan. CT simulation scanners produce images with high HU accuracy and are regularly used for radiation treatment planning. Here, we present the difference in HU between CT simulation images and different CBCT images. ΔHU = HU\_CBCT - HU\_CTSim, where HU\_CBCT and HU\_CTSim are mean values among HU averages at 4 reference points in a CBCT image and the corresponding CT simulation image, respectively. The lower the ΔHU, the greater the HU accuracy of the CBCT image, and the greater the likelihood that CBCT imaging can be used for radiation treatment planning. Median ΔHU across the study population are presented for three different tissue types for three CBCT imaging modalities.

Time frame:
1 week
Reported as:
Median · HU
CBCT Image Quality - HU Similarity to CT Simulation
HUBreath Hold High Performance CBCTFree Breathing High Performance CBCTConventional CBCT
Bone-12.1 (-25.8 to 9.9)-31.4 (-58.6 to -11.7)6.7 (-33.0 to 39.5)
Lung-14.0 (-32.3 to 2.5)85.0 (12.6 to 111.3)-33.0 (-69.0 to -9.5)
Tissue-0.8 (-12.1 to 6.9)-11.3 (-30.6 to 4.9)-18.7 (-30.3 to -6.7)
SecondaryDosimetry Calculations - Gamma Pass Rate

Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. The overall difference between calculated radiation distributions was evaluated using three different gamma pass criteria: 3% dose difference / 3 mm distance to agreement, 2%/2mm, and 1%/1mm. The gamma pass rate is expressed as a percentage of data points that meet the pass criteria. A gamma pass rate of \> 95% is typically considered acceptable for 3%/3mm. As the gamma pass criteria become stricter, the pass rates decrease. Gamma pass rates were calculated to compare the CT simulation-based dose calculation and the high performance CBCT-based dose calculation. Gamma pass rates were also calculated to compare the CT simulation-based dose calculation and the conventional CBCT-based dose calculation. The median gamma pass rates across the entire study population are presented.

Time frame:
1 day
Reported as:
Median · percentage
Dosimetry Calculations - Gamma Pass Rate
percentageBreath Hold High Performance CBCTConventional CBCT
3%/3mm96.7 ± 3.193.3 ± 14
2%/2mm89.9 ± 6.085.4 ± 18.4
1%/1mm70.2 ± 11.861.6 ± 22.4
SecondaryDosimetry Calculations - Target DVH Volume Metrics

Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH metrics, such as V90(%) (the percentage of the structure volume receiving 90% of the prescribed radiation dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.

Time frame:
1 day
Reported as:
Median · % target volume (Vxx)
Dosimetry Calculations - Target DVH Volume Metrics
% target volume (Vxx)Breath Hold High Performance CBCTConventional CBCT
V90(%)0.1 (-0.7 to 0.9)0.0 (-1.0 to 1.0)
V95(%)0.3 (-3.4 to 4.0)0.0 (-2.9 to 2.9)
V100(%)1.5 (-8.2 to 11.2)0.2 (-10.7 to 11.1)
V105(%)-0.9 (-4.0 to 5.8)-2.7 (-13 to 7.6)
SecondaryDosimetry Calculations - Target DVH Dose Metrics

Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH dose metrics, such as D95(%) (the minimum dose covering 95% of the structure, expressed as a % of the prescription dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.

Time frame:
1 day
Reported as:
Median · % prescription dose (Dxx)
Dosimetry Calculations - Target DVH Dose Metrics
% prescription dose (Dxx)Breath Hold High Performance CBCTConventional CBCT
D90(%)0.5 (-2.2 to 3.2)0.0 (-3.1 to 3.1)
D95(%)1.0 (-3.5 to 5.5)0.5 (-3.2 to 4.2)
D99(%)2.2 (-3.7 to 8.1)1.5 (-10.2 to 13.2)
Dmax(%)-2.3 (-5.4 to 0.8)-2.4 (-7.6 to 2.8)
SecondaryDosimetry Calculations - Breast OAR DVH Metrics

Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for breast cancer are the heart, ipsilateral lung, and contralateral breast. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for breast cancer are presented.

Time frame:
1 day
Reported as:
Median · % dose
Dosimetry Calculations - Breast OAR DVH Metrics
% doseBreath Hold High Performance CBCTConventional CBCT
Heart D2%(%)-1.4 (-4.4 to 2.6)-2.7 (-9.3 to 3.9)
Ipsilateral lung D2%(%)1.1 (-1.6 to 3.8)2.9 (-0.2 to 6.0)
Contralateral breast D2%(%)0.1 (-1.2 to 1.4)0.5 (-0.5 to 1.5)
SecondaryDosimetry Calculations - Lung OAR DVH Metrics

Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for lung cancer are the heart, esophagus and spinal cord. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for lung cancer are presented.

Time frame:
1 day
Reported as:
Median · % dose
Dosimetry Calculations - Lung OAR DVH Metrics
% doseBreath Hold High Performance CBCTConventional CBCT
Heart D2%(%)-0.3 (-1.2 to 0.6)-0.1 (-1.3 to 1.1)
Esophagus D2%(%)0.1 (-1.3 to 1.5)-0.2 (-1.1 to 0.7)
Spinal cord D2%(%)-0.4 (-1.0 to 0.2)-0.1 (-0.9 to 0.7)
SecondaryDosimetry Calculations - Abdomen OAR DVH Metrics

Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for abdominal cancer are the heart, bowel and kidneys. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for abdominal cancer are presented.

Time frame:
1 day
Reported as:
Median · % dose
Dosimetry Calculations - Abdomen OAR DVH Metrics
% doseBreath Hold High Performance CBCTConventional CBCT
Heart D2%(%)0.7 (-0.5 to 1.9)-0.8 (-3.1 to 1.5)
Bowel D2%(%)-0.2 (-1.7 to 1.3)-0.6 (-1.8 to 0.6)
Kidneys D2%(%)-0.1 (-2.3 to 2.1)0.0 (-0.9 to 0.9)
SecondaryPatient Experience - General Ease of Breath Hold

Study participants were asked to respond to the statement, "I find it easy to hold my breath", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

Time frame:
1 Day
Reported as:
Mean · Units on a Likert scale
Patient Experience - General Ease of Breath Hold
Units on a Likert scaleHigh-performance CBCT Imaging
Patient Experience - General Ease of Breath Hold4.3 ± 0.47
SecondaryPatient Experience - Ease of Breath Hold on TrueBeam

Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds that were needed for imaging on the TrueBeam radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

Time frame:
1 Day
Reported as:
Mean · Units on a Likert scale
Patient Experience - Ease of Breath Hold on TrueBeam
Units on a Likert scaleHigh-performance CBCT Imaging
Patient Experience - Ease of Breath Hold on TrueBeam4.3 ± 0.48
SecondaryPatient Experience - Ease of Breath Hold on Ethos

Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds needed for imaging on the Ethos radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

Time frame:
1 Day
Reported as:
Mean · Units on a Likert scale
Patient Experience - Ease of Breath Hold on Ethos
Units on a Likert scaleHigh-performance CBCT Imaging
Patient Experience - Ease of Breath Hold on Ethos4.5 ± 0.51
SecondaryPatient Experience - Relative Ease of Breath Hold Between Machines

Study participants were asked to respond to the statement, "It was easier for me to perform the breath holds needed for imaging on one radiation machine compared to the other", on a 5-point scale, where 1 represents "TrueBeam much easier", 3 represents "Both machines equally easy", and 5 represents "Ethos much easier".

Time frame:
1 Day
Reported as:
Mean · Units on a Likert scale
Patient Experience - Relative Ease of Breath Hold Between Machines
Units on a Likert scaleHigh-performance CBCT Imaging
Patient Experience - Relative Ease of Breath Hold Between Machines4.2 ± 0.99
SecondaryPatient Experience - Overall TrueBeam Experience

Study participants were asked to respond to the statement, "My overall experience during imaging on the TrueBeam was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

Time frame:
1 Day
Reported as:
Mean · Units on a Likert scale
Patient Experience - Overall TrueBeam Experience
Units on a Likert scaleHigh-performance CBCT Imaging
Patient Experience - Overall TrueBeam Experience4.4 ± 0.68
SecondaryPatient Experience - Overall Ethos Experience

Study participants were asked to respond to the statement, "My overall experience during imaging on the Ethos platform was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".

Time frame:
1 Day
Reported as:
Mean · Units on a Likert scale
Patient Experience - Overall Ethos Experience
Units on a Likert scaleHigh-performance CBCT Imaging
Patient Experience - Overall Ethos Experience4.5 ± 0.51

Adverse events

Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High-performance CBCT Imaging0/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)High-performance CBCT Imaging
Median66 ± 8.2
Sex: Female, Male
Sex: Female, Male(Participants)High-performance CBCT Imaging
Female18
Male12
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)High-performance CBCT Imaging
BMI
BMI(kg/m^2)High-performance CBCT Imaging
Mean29.2 (19.2 to 38.1)
08

Study locations

1 site
  • Nova Scotia Health (QEII)
    Halifax, Nova Scotia B3H 2E2, Canada
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 24, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05176860
Lead sponsor
Varian, a Siemens Healthineers Company
Responsible party
Sponsor
First posted
Jan 4, 2022
Start date
Dec 20, 2022
Primary completion
Jul 30, 2023
Completion
Jul 30, 2023
Results posted
May 6, 2026
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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