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

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ClinicalTrials.gov Identifier: NCT04545957
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : November 14, 2023
Sponsor:
Information provided by (Responsible Party):
Raymond Mak, MD, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Recurrent Adenocarcinoma Liver Cancer Head and Neck Cancer Device: MRI Simulator Radiation: Radiation Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments
Actual Study Start Date : October 14, 2020
Estimated Primary Completion Date : November 10, 2024
Estimated Study Completion Date : October 22, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545957


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

Locations
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United States, Massachusetts
Brigham and Women Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Raymond Mak, MD       rmak@partners.org   
Principal Investigator: Raymond Mak, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Raymond Mak, MD       rmak@partners.org   
Principal Investigator: Raymond Mak, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Raymond Mak, MD Brigham and Women's Hospital
More Information
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Responsible Party: Raymond Mak, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04545957    
Other Study ID Numbers: 19-759
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: November 14, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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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
Keywords provided by Raymond Mak, MD, Dana-Farber Cancer Institute:
Prostate Cancer
Recurrent Adenocarcinoma
Liver Cancer
Head and Neck Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Head and Neck Neoplasms
Liver Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases