Brain Cancer, Head and Neck Cancer, Lung Cancer
Conditions
Brief summary
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.
Interventions
DEVICESiemens Somatom Definition Edge
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.
DEVICEPhilips 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.
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: Inclusion Criteria: * Diagnosis of histologically proven primary or metastatic cancer requiring thoracic radiation therapy OR radiation therapy to the head and neck or brain * At least 18 years of age. * Planning to undergo proton or photon beam radiation therapy as part of the clinical management of the diagnosed cancer. * Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion criteria
* Implanted metallic objects in the region to be scanned excepting dental prostheses * IV or oral contrast medium within 24 hours prior to DECT image acqusition * Pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT | Day 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dual-Energy CT Scan Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not imaged due to issues during the pandemic | 16 |
Baseline characteristics
| Characteristic | Dual-Energy CT Scan |
|---|---|
| Age, Continuous | 66.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT
Time frame: Day 1
Population: 16 participants did not have imaging due to staffing changes and lack of communication during the pandemic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dual-Energy CT Scan | Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT | Head and Neck Patients | 0.9 percentage relative to prescribed dose | Standard Deviation 1.8 |
| Dual-Energy CT Scan | Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT | Lung Patients | 1.0 percentage relative to prescribed dose | Standard Deviation 2.8 |