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NCT Number: NCT04545957

Jump: MR Simulation For Radiation Therapy Master Protocol

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of acquiring MRI simulation prior to radiation therapy planning

    Time frame: 1 Year

    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

  2. Proportion of patients with QOL decline exceeding 2 x MID

    Time frame: baseline up to 24 months

    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

Secondary outcomes

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

    Time frame: 24 Months

  2. MRI evidence of disease at 2 years from treatment initiation.

    Time frame: 24 Months

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

    Time frame: 24 months

  4. Progression free survival

    Time frame: 24 months

  5. Change in target volumes between CT simulation and MRI simulation

    Time frame: 24 Months

    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.

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

    Time frame: 24 Months

    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.

  7. Change in dose to organs at risk (OARs) between CT simulation and MRI simulation

    Time frame: 24 Months

    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.

  8. Performance of the synthetic CT in RT planning

    Time frame: 24 Months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Mak, MD

CONTACT

[email protected]

617-632-5734

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Acronym: JUMP

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Sep 11, 2020
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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