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
1 other identifier
interventional
86
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Oct 2020
Longer than P75 for not_applicable prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2020
CompletedFirst Posted
Study publicly available on registry
September 11, 2020
CompletedStudy Start
First participant enrolled
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 22, 2030
July 28, 2025
May 1, 2025
10 years
September 4, 2020
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
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
Progression free survival
24 months
Change in target volumes between CT simulation and MRI simulation
24 Months
- +3 more secondary outcomes
Study Arms (3)
Phase I MRI Simulation
EXPERIMENTALThis 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.
Phase II MR Simulation Protocol: Track A
EXPERIMENTALMR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
Phase II MR Simulation Protocol: Track B
EXPERIMENTALAdjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
Interventions
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.
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Mak, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2020
First Posted
September 11, 2020
Study Start
October 14, 2020
Primary Completion (Estimated)
October 22, 2030
Study Completion (Estimated)
October 22, 2030
Last Updated
July 28, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.