Abdominal Cancer, Liver Cancer, Adult, Lung Cancer (Diagnosis), Pancreatic Cancer, Thoracic Cancers
Conditions
Keywords
Stereotactic body radiation therapy, Lung cancer, Liver cancer, Pancreatic cancer, Thoracic cancer, abdominal cancer, Breath hold, DMAT, linac, motion monitoring, linear accelerator, kV fluoroscopy, C-arm
Brief summary
The purpose of this research is to evaluate the "Next Generation Delivery System" (NGDS) and determine if this machine will be more efficient at delivering radiation in shorter treatment time and better patient tolerance, with less breath holding.
Detailed description
This study is a prospective multi-center clinical trial. It is designed to evaluate the feasibility of a breath hold workflow on a new treatment platform (NGDS DMAT). Eligible participants will be receiving stereotactic body radiotherapy (SBRT) under breath hold conditions to targets in the thorax and upper abdomen as part of their routine care. Enrolled participants will be asked to undergo a mock treatment on this new treatment platform under breath hold conditions. Participant images for set up and alignment will be obtained on the NGDS.
Interventions
DEVICENext Generation Delivery System (NGDS)
Participant will receive a "mock" treatment on the NGDS machine. Participant will complete experience questionnaires.
Sponsors
Varian, a Siemens Healthineers Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Target lesions in the thorax or upper abdomen 2. Planned to undergo SBRT radiation treatment delivered on a conventional "C-arm" or ring gantry CBCT guided linear accelerator under breath hold conditions 3. ECOG performance status 0-1 4. At least 21 years of age 5. Able to sign informed consent
Exclusion criteria
1. Participants enrolled in another clinical investigation the investigator believes to be in conflict with this clinical investigation. 2. Participants with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the feasibility of the mock NGDS DMAT workflow under breath hold conditions. | From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months | Feasibility of the mock NGDS DMAT treatment workflow under breath hold conditions will be confirmed following successful execution of each step: 1. Acquisition of an IDENTIFY-monitored breath hold kV HyperSight CBCT 2. Conduct verification imaging of shifts and breath hold position using kV fluoroscopy 3. Delivery of an investigator approved "mock" DMAT treatment plan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To quantify the number of breath holds required. | From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months | Record and compare the number of breath holds required by the participant to complete treatment beam delivery on the NGDS to the number of breath holds required on the conventional treatment machine. |
| To assess the participant's experience of the conventional treatment and mock NGDS DMAT treatment. | From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months | Participant survey to assess the experience of treatment on the conventional machine and mock treatment on the NGDS. |
| To quantify all temporal aspects of the NGDS DMAT and conventional treatment sessions. | From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months | Measuring and recording the time required for each workflow step in both conventional treatment and mock NGDS DMAT treatment. |
| To create a DMAT dosimetry plan judged clinically acceptable for treatment. | From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months | The NGDS DMAT plan must be judged by the attending physician to be clinically similar to the conventional SBRT plan (i.e. the same clinical goals will be used to evaluate both plans), and acceptable for treatment. |
| To assess patient-specific quality assurance results for DMAT plans. | From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months | Delivery quality assurance and dose calculation accuracy will be measured by institutional-specific QA equipment (compliant with AAPM (American Association of Physicists in Medicine) Task Group 218). |
| To assess the feasibility of intra-fraction motion monitoring with triggered imaging. | From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months | Success of intra-fraction motion monitoring imaging will be measured by the ability to carry out triggered imaging in one second intervals (or as dictated by the treatment plan). |
Countries
United States
Contacts
CONTACTJennifer Woo
Outcome results
None listed