Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Dana Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Raymond Mak, MD
rmak@partners.org

More Details

Status
Recruiting
Sponsor
Dana-Farber Cancer Institute

Study Contact

Raymond Mak, MD
617-632-5734
rmak@partners.org

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.