Jump: MR Simulation For Radiation Therapy Master Protocol (JUMP)

Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Prostate Cancer; Liver Cancer; Recurrent Adenocarcinoma
• Intervention / Treatment: Device: MRI Simulator; Radiation: Radiation Therapy

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 Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Mak, MD; Phone Number: 617-632-5734; Email: rmak@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Raymond Mak, MD; Email: rmak@partners.org
      • Principal Investigator: Raymond Mak, MD
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women Hospital
      • Contact: Raymond Mak, MD; Email: rmak@partners.org
      • Principal Investigator: Raymond Mak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	baseline up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival		24 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0		24 Months
MRI evidence of disease at 2 years from treatment initiation.		24 Months
PSA progression (nadir + 2) at 2 years from treatment initiation		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.	24 Months
Change in coverage of target volumes between CT simulation and MRI simulation	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.	24 Months
Change in dose to organs at risk (OARs) between CT simulation and MRI simulation	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.	24 Months
Performance of the synthetic CT in RT planning	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	24 Months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Raymond Mak, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Estimated): November 10, 2024
• Study Completion (Estimated): October 22, 2026

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Prostate Cancer; Liver Cancer; Recurrent Adenocarcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Genital Neoplasms, Male; Liver Diseases; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Head and Neck Neoplasms; Prostatic Neoplasms; Adenocarcinoma; Liver Neoplasms
• Other Study ID Numbers: 19-759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes