An interventional study of Siemens Somatom Definition Edge and Philips Brilliance Big Bore CT/simulator in Lung Cancer, Brain Cancer and Head and Neck Cancer, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic
The aim of this protocol is to refine the accuracy of proton beam therapy (PT) by the use of dual energy computed tomography (DECT), in conjunction with novel iterative image reconstruction algorithms, to more precisely determine the tissue properties through which the proton beam path travels.
Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan.
Device: Siemens Somatom Definition Edge · Device: Philips Brilliance Big Bore CT/simulator
In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study.
In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study.
Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT
Time frame: Day 1
| Milestone | Dual-Energy CT Scan |
|---|---|
| Started | 36 |
| Completed | 20 |
| Not completed | 16 |
| Withdrew: Not imaged due to issues during the pandemic | 16 |
| percentage relative to prescribed dose | Dual-Energy CT Scan |
|---|---|
| Head and Neck Patients | 0.9 ± 1.8 |
| Lung Patients | 1.0 ± 2.8 |
Collected over Adverse events and all-cause mortality were followed for 1 day.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dual-Energy CT Scan | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Dual-Energy CT Scan |
|---|---|
| Median | 66.5 (22 to 86) |
| Sex: Female, Male(Participants) | Dual-Energy CT Scan |
|---|---|
| Female | 15 |
| Male | 21 |
| Ethnicity (NIH/OMB)(Participants) | Dual-Energy CT Scan |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 34 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Dual-Energy CT Scan |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Dual-Energy CT Scan |
|---|---|
| United States | 36 |
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Washington University School of Medicine