Overview
This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.
Description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the feasibility and safety of an investigational intervention. "Investigational" means that the process targeting high doses of radiation to the tumor based on MRI is still being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided dose planning. The U.S. Food and Drug Administration (FDA) has cleared MRI planning for use.
- In Phase I of this study, will prospectively determine the feasibility of using an MRI simulator to plan radiation therapy.
- In Phase II, the efficacy of adjusting RT based on MRI simulation will be explored, either by utilizing an MRI-simulation and synthetic CT to plan treatment or by dose-painting based on functional MRI data
Eligibility
Inclusion Criteria:
- Participants must have a confirmed malignancy requiring radiation therapy.
- Age: 18 years or older
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
- Disease-specific eligibility criteria will be specified in the appropriate subprotocol.
Exclusion Criteria:
- For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast. Note: If patient will not receive contrast, this is not applicable
- Participants who cannot undergo an MRI
- Disease-specific exclusion criteria will be specified in the appropriate subprotocol