This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.
Participants must have histologically or cytologically confirmed malignancy requiring radiation
Age 18 years of older
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Ability to understand and the willingness to sign a written informed consent document.
History of allergic reactions attributed to gadolinium-based IV contrast
Severe claustrophobia or anxiety
Participants who cannot undergo an MRI
Any other exclusion criteria listed in the specific disease site cohort
Parallel
Viewray MRIdian® Linac
RadiationMR-image guided radiation will be administered per disease site standards.
Number of Patients and delivering MR-image guided radiation-Phase I
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac
Tumor Assessment with MR Guidance-Phase I
Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as assessing tumor using MR guidance before, during and after MR-guided treatment patient.
Patient reported outcomes (PROMs) -Phase II
PROMs are collected at patient visits. PROMs will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS Global-10 metric collects information on symptoms and quality of life.
1-year tumor control-Phase II
Tumor response 1 year after radiation treatment
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
CTCAE version 5.0.
Duration of treatment with goal of >80% of cases treated within 90 minutes
Total time of treatment for each fraction
Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.
Importance of MR-guidance
Click on the lead sponsor to view all of their trials.
