Clinical trial NCT04545957: Jump: MR Simulation For Radiation Therapy Master Protocol
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
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Recurrent Adenocarcinoma
Liver Cancer
Head and Neck Cancer
Keywords: Prostate Cancer
Recurrent Adenocarcinoma
Liver Cancer
Head and Neck Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Feasibility of acquiring MRI simulation prior to radiation therapy planning
timeFrame: 1 Year
measure: Proportion of patients with QOL decline exceeding 2 x MID
timeFrame: baseline up to 24 months
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 24 Months
measure: MRI evidence of disease at 2 years from treatment initiation.
timeFrame: 24 Months
measure: PSA progression (nadir + 2) at 2 years from treatment initiation
timeFrame: 24 months
measure: Progression free survival
timeFrame: 24 months
measure: Change in target volumes between CT simulation and MRI simulation
timeFrame: 24 Months
measure: Change in coverage of target volumes between CT simulation and MRI simulation
timeFrame: 24 Months
measure: Change in dose to organs at risk (OARs) between CT simulation and MRI simulation
timeFrame: 24 Months
measure: Performance of the synthetic CT in RT planning
timeFrame: 24 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Raymond Mak, MD
role: PRINCIPAL_INVESTIGATOR
References: