Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Feasibility of acquiring MRI simulation prior to radiation therapy planning
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Phase II MR Simulation Protocol: Track A
MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
Intervention: MRI Simulator (Device)
Phase II MR Simulation Protocol: Track B
Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
Intervention: MRI Simulator (Device)
Phase II MR Simulation Protocol: Track B
Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
Intervention: Radiation Therapy (Radiation)
Phase I MRI Simulation
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.
Intervention: MRI Simulator (Device)
Phase I MRI Simulation
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.
Intervention: Radiation Therapy (Radiation)
Phase II MR Simulation Protocol: Track A
MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
Intervention: Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Feasibility of acquiring MRI simulation prior to radiation therapy planning
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- Change in dose to organs at risk (OARs) between CT simulation and MRI simulation(24 Months)
- Change in target volumes between CT simulation and MRI simulation(24 Months)
- Performance of the synthetic CT in RT planning(24 Months)
Investigators
Raymond Mak
Principal Investigator
Brigham and Women's Hospital