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

Primary Purpose

Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI Simulator
Radiation Therapy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 gadoliniumbased 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

Sites / Locations

  • Brigham and Women HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase I MRI Simulation

Phase II MR Simulation Protocol: Track A

Phase II MR Simulation Protocol: Track B

Arm Description

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.

MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment

Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
MRI evidence of disease at 2 years from treatment initiation.
PSA progression (nadir + 2) at 2 years from treatment initiation
Progression free survival
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.
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.
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.
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

Full Information

First Posted
September 4, 2020
Last Updated
January 9, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04545957
Brief Title
Jump: MR Simulation For Radiation Therapy Master Protocol
Acronym
JUMP
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck Cancer
Keywords
Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase I MRI Simulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase II MR Simulation Protocol: Track A
Arm Type
Experimental
Arm Description
MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment
Arm Title
Phase II MR Simulation Protocol: Track B
Arm Type
Experimental
Arm Description
Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging)
Intervention Type
Device
Intervention Name(s)
MRI Simulator
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of acquiring MRI simulation prior to radiation therapy planning
Description
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
Title
Proportion of patients with QOL decline exceeding 2 x MID
Description
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 Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
24 Months
Title
MRI evidence of disease at 2 years from treatment initiation.
Time Frame
24 Months
Title
PSA progression (nadir + 2) at 2 years from treatment initiation
Time Frame
24 months
Title
Progression free survival
Time Frame
24 months
Title
Change in target volumes between CT simulation and MRI simulation
Description
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
Title
Change in coverage of target volumes between CT simulation and MRI simulation
Description
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.
Time Frame
24 Months
Title
Change in dose to organs at risk (OARs) between CT simulation and MRI simulation
Description
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.
Time Frame
24 Months
Title
Performance of the synthetic CT in RT planning
Description
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
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 gadoliniumbased 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Mak, MD
Phone
617-632-5734
Email
rmak@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Mak, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Mak, MD
Email
rmak@partners.org
First Name & Middle Initial & Last Name & Degree
Raymond Mak, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Mak, MD
Email
rmak@partners.org
First Name & Middle Initial & Last Name & Degree
Raymond Mak, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Jump: MR Simulation For Radiation Therapy Master Protocol

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