Jump: MR Simulation For Radiation Therapy Master Protocol

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04545957
• Other study ID #: 19-759
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: October 22, 2026

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: Raymond Mak, MD
• Phone: 617-632-5734
• Email: rmak[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: October 22, 2026
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Head and Neck Cancer
• Head and Neck Neoplasms
• Liver Cancer
• Liver Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Recurrent Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0		24 Months
Secondary	MRI evidence of disease at 2 years from treatment initiation.		24 Months
Secondary	PSA progression (nadir + 2) at 2 years from treatment initiation		24 months
Secondary	Progression free survival		24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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