An observational study in Head and Neck Cancer, Breast Cancer and Upper Gastrointestinal Cancer, sponsored by Varian, a Siemens Healthineers Company. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Varian, a Siemens Healthineers Company · Observational
The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →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.
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Patients receiving radiation therapy in one of five anatomical regions: head/neck, breast, lungs, upper GI and pelvis.
Exclusion Criteria:
Subjects are imaged with the new HyperSight CBCT imaging system.
Device: HyperSight Imaging
Patients receive standard of care radiation treatment on a Varian TrueBeam system equipped with HyperSight CBCT imaging. Images acquired for daily patient positioning from two different treatment fractions - typically one near the beginning of the treatment course and one at about the halfway point - will be analyzed for the study.
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.
To evaluate the feasibility of HyperSight CBCT as a method for CBCT-based re-planning by measuring the fraction of patients whose HyperSight imaging meets criteria for potential CBCT-based treatment planning using HyperSight CBCT. The criteria include visibility of all key anatomical structures, image quality sufficient to contour anatomical structures, and clinically acceptable dose accuracy.
Time frame: 1 year
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site
To break down the fraction of patients that meet criteria for potential CBCT-based treatment planning using HyperSight CBCT by anatomical site (head/neck, breast, lungs, upper GI tract, and pelvis).
Time frame: 1 year
Image noise
To evaluate the imaging noise in HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Time frame: 1 year
Image low-contrast resolution
To evaluate contrast between adjacent anatomical structures in HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Time frame: 1 year
Image contrast-to-noise ratio
To measure the contrast-to-noise ratio of HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Time frame: 1 year
Qualitative assessment of motion artifacts
To evaluate the severity of motion artifacts observed in HyperSight CBCT using clinical images and to compare motion artifacts to simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale.
Time frame: 1 year
Qualitative assessment of metal artifacts
To evaluate the severity of metal artifacts observed in HyperSight CBCT in head \& neck patients with dental fillings and pelvis patients with hip prostheses and compare metal artifacts between HyperSight CBCT and simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale, with a score of 1 representing very severe metal artifacts and a score of 5 representing little or no artifact..
Time frame: 1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
To evaluate concordance of anatomical structures contoured on HyperSight with anatomical structures contoured on simulation CT as measured by the Dice Similarity Coefficient.
Time frame: 1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
To evaluate concordance of anatomical structures contoured on HyperSight with anatomical structures contoured on simulation CT as measured by Hausdorff Distance.
Time frame: 1 year
Breath hold tolerance
To evaluate the number of breath holds required for patients with breast, thoracic, and upper GI malignancies during HyperSight CBCT imaging.
Time frame: 1-9 weeks
Patient experience of HyperSight imaging
To evaluate patient experience of HyperSight imaging. Patients will be asked to fill out a questionnaire. Questions will use a 5-point Likert scale.
Time frame: 1-9 weeks
Impact of noise suppression
HyperSight CBCT images will be reconstructed with different levels of noise suppression and compared qualitatively to CT simulation images of the same patient to identify regions adversely affected by too much or too little noise suppression. This evaluation will be performed for 1-2 subjects in each anatomical region.
Time frame: 1 year
Effectiveness of AI auto-contouring
The ability of AI auto-contouring to accurately contour structures on Hy\[erSight CBCT will be evaluated (i) via qualitative user feedback on the accuracy of the auto-generated contours, and (ii) quantitatively using overlap metrics (Hausdorff Distance and Dice Similarity Coefficient) to compare auto-generated critical organs at risk to anatomical structures manually contoured on HyperSight CBCT.
Time frame: 1 year
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Varian, a Siemens Healthineers Company