Jump: MR Simulation For Radiation Therapy Master Protocol
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
86Conditions
Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck CancerSummary
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.
Detailed 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
Locations
2 locations Found with status Recruiting
Eligibility Criteria
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
Study Plan
Phase I MRI Simulation
EXPERIMENTAL
This research study involves a screening period to determine eligibility.nn- Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.
DEVICE:
MRI SimulatorDescription:
Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.RADIATION:
Radiation TherapyDescription:
In Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols.
Phase II MR Simulation Protocol: Track A
EXPERIMENTAL
MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
DEVICE:
MRI SimulatorDescription:
Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.RADIATION:
Radiation TherapyDescription:
In Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols.
Phase II MR Simulation Protocol: Track B
EXPERIMENTAL
Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
DEVICE:
MRI SimulatorDescription:
Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.RADIATION:
Radiation TherapyDescription:
In Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols.
Outcome Measures
Primary Outcome Measures
Feasibility of acquiring MRI simulation prior to radiation therapy planning
Proportion of patients with QOL decline exceeding 2 x MID
Secondary Outcome Measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
MRI evidence of disease at 2 years from treatment initiation.
PSA progression (nadir + 2) at 2 years from treatment initiation
Progression free survival
Change in target volumes between CT simulation and MRI simulation
Change in coverage of target volumes between CT simulation and MRI simulation
Change in dose to organs at risk (OARs) between CT simulation and MRI simulation
Performance of the synthetic CT in RT planning
Timeline
Last Updated
November 14, 2023Start Date
September 11, 2020Today
January 16, 2025Completion Date ( Estimated )
October 22, 2026
Sponsors of this trial
Lead Sponsor
Dana-Farber Cancer Institute
RECRUITING 
21 - 64 Years