Jump: MR Simulation For Radiation Therapy Master Protocol

Brigham and Women's Hospital86 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Recurrent Adenocarcinoma Liver Cancer Head and Neck Cancer

Interventions

MRI SimulatorDEVICE

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 TherapyRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Brigham and Women Hospital

Boston, Massachusetts, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Feasibility of acquiring MRI simulation prior to radiation therapy planning

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

Time frame: 1 Year

Proportion of patients with QOL decline exceeding 2 x MID

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

Time frame: baseline up to 24 months

Secondary Outcomes

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time frame: 24 Months

MRI evidence of disease at 2 years from treatment initiation.

Time frame: 24 Months

PSA progression (nadir + 2) at 2 years from treatment initiation

Time frame: 24 months

Progression free survival

Time frame: 24 months

Change in target volumes between CT simulation and MRI simulation

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.

Time frame: 24 Months

Change in coverage of target volumes between CT simulation and MRI simulation

Central Contacts

Raymond Mak, MD

CONTACT

617-632-5734 rmak@partners.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.