Jump: MR Simulation For Radiation Therapy Master Protocol
- Conditions
- Liver CancerProstate CancerRecurrent AdenocarcinomaHead and Neck Cancer
- Interventions
- Device: MRI SimulatorRadiation: Radiation Therapy
- Registration Number
- NCT04545957
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase II MR Simulation Protocol: Track B MRI Simulator Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging) Phase II MR Simulation Protocol: Track A Radiation Therapy MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment Phase II MR Simulation Protocol: Track B Radiation Therapy Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging) Phase I MRI Simulation Radiation Therapy This research study involves a screening period to determine eligibility. - 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. Phase I MRI Simulation MRI Simulator This research study involves a screening period to determine eligibility. - 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. Phase II MR Simulation Protocol: Track A MRI Simulator MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
- Primary Outcome Measures
Name Time Method Feasibility of acquiring MRI simulation prior to radiation therapy planning 1 Year Feasibility is defined as successfully enrolling patients, successfully 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
Proportion of patients with QOL decline exceeding 2 x MID baseline up to 24 months 12 points; MID of the EPIC-26 urinary irritative/obstructive domain is 6 points) measured by EPIC-26 urinary irritation/obstruction domain from baseline to 2 years
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 24 Months PSA progression (nadir + 2) at 2 years from treatment initiation 24 months MRI evidence of disease at 2 years from treatment initiation. 24 Months Progression free survival 24 months Change in coverage of target volumes between CT simulation and MRI simulation 24 Months The dose to OARS using the CT-simulation and MR-simulation derived plans will be compared using the t-test for normal data or Wilcoxon signed-rank test if data does not follow a normal distribution.
Change in dose to organs at risk (OARs) between CT simulation and MRI simulation 24 Months The dose to OARS using the CT-simulation and MR-simulation derived plans will be compared using the t-test for normal data or Wilcoxon signed-rank test if data does not follow a normal distribution.
Change in target volumes between CT simulation and MRI simulation 24 Months To ascertain the effects of MRI simulation on size of target volumes and OAR, the volume (cc) will be compared between CT vs MR simulation by t-test for normal data or Wilcoxon signed-rank test if data does not follow a normal distribution. The extent of overlap calculated with the Sorensen-Dice coefficient and Hausdorff distance.
Performance of the synthetic CT in RT planning 24 Months To assess performance of the synthetic CT in RT planning, fluence patterns from the synthetic CT plan will be copied onto the CT simulation electron density grids and dose recalculated. Accuracy of synthetic CT dose calculations to target volumes and OARs will be assessed with a goal of \<1% difference in target and OAR dose between synthetic CT plans and CT simulation plans
Trial Locations
- Locations (2)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Brigham and Women Hospital
🇺🇸Boston, Massachusetts, United States