MRI Simulator
DeviceRadiation 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.
NCT Number: NCT04545957
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brigham and Women Hospital, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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
Time frame: 24 Months
Time frame: 24 Months
Time frame: 24 months
Time frame: 24 months
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.
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.
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.
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
Contact information is provided by the study sponsor or research team.
Brigham and Women's Hospital
Other
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
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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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