Jump: MR Simulation For Radiation Therapy Master Protocol

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04545957
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRI Simulator — DEVICE
    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 Therapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Oct 14, 2020
Status verified
May 2025
Primary completion
Oct 22, 2030
Completion
Oct 22, 2030

Study Design

Enrollment
86 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: Phase II MR Simulation Protocol: Track A
    MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
  • Experimental: 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)

Primary Outcome Measure

Feasibility of acquiring MRI simulation prior to radiation therapy planning [ Time Frame: 1 Year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women HospitalBostonMassachusetts02115
Raymond Mak, MD
[email protected]
Raymond Mak, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Raymond Mak, MD
[email protected]
Raymond Mak, MD (PRINCIPAL_INVESTIGATOR)

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