Brain Cancer, Colon Cancer, Gastric Cancer, Head and Neck Cancer, Lung Cancer, Ovarian Cancer
Conditions
Keywords
radiation therapy, halcyon, brain radiation, thoracic radiation, abdominal radiation, pelvic radiation
Brief summary
This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically validated for use in radiation planning. This pilot study will evaluate images obtained on the Halcyon 4.0 system to assess if the quality is sufficient for radiation treatment plan construction.
Interventions
DEVICEHalcyon 4.0 system
During each of the 1 or more imaging sessions, no more than 6 images total will be acquired. Only 5 images total across all of the imaging sessions will be used toward the study endpoint.
Sponsors
Varian Medical Systems
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: * Planning to receive radiation therapy to one of the following sites: * Head and neck/brain (n=10) * Thorax (n=10) * Abdomen (n=10) * Pelvis (n=10) * At least 18 years of age * If the patient will be receiving IV contrast on study: Adequate renal function as defined by a serum creatinine \< 1.4, or, for patients with chronic kidney disease, a stable serum creatinine \< 2.0. Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented. * If the patient is a woman of childbearing potential, a negative pregnancy test must be obtained. Contraceptive use is not an adequate documentation of no chance of pregnancy. * Able to understand and willing to sign an IRB approved written informed consent document.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of images that are of sufficient quality for patient primary treatment plan construction | At 9 weeks | If the treatment target and surrounding organs at risk can be visualized and contoured for treatment planning purposes and a treatment plan created that meets the stated objectives ( or better than the stated objectives), then the kV CBCT images will be deemed feasible. |
Countries
United States
Outcome results
None listed