This phase I/II trial studies how well magnetic resonance imaging simulation works for the planning of radiation therapy compared to traditional planning with computed tomography (CT) scans in cancer patients. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The use of magnetic resonance imaging during radiation simulation may improve outcomes and accuracy of treatment planning in cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04545957.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Raymond H. Mak
Phone: 617-632-3591
Brigham and Women's HospitalStatus: Active
Contact: Raymond H. Mak
Phone: 617-632-3591
PRIMARY OBJECTIVES:
I. To determine feasibility of acquiring magnetic resonance imaging (MRI) simulation prior to radiation therapy planning. (Phase I)
II. To determine if adapting treatment based on MRI simulation improves patient-reported outcomes (PROMs) as compared to historically reported patient-reported outcome measures. (Phase II)
SECONDARY OBJECTIVE:
I. To evaluate tumor control. (Phase II)
II. Objectives per disease site subprotocol. (Phase II)
EXPLORATORY OBJECTIVES:
I. To investigate radiographic and biologic biomarkers predictive of response to radiation.
II. To evaluate cost-effectiveness, operational efficiency, and patient satisfaction with magnetic resonance (MR) simulation.
OUTLINE:
PHASE I: Patients undergo radiation therapy treatment planning and MRI and computed tomography (CT) simulation. Patients then undergo standard of care radiation therapy.
PHASE II: Patients are assigned to 1 of 2 tracks.
TRACK A: Patients undergo radiation therapy treatment planning and MRI simulation. Patients then undergo standard of care radiation therapy.
TRACK B: Patients undergo radiation therapy treatment planning and MRI and CT simulation. Patients then undergo standard of care radiation therapy based on MRI data such as biological imaging, either with dose painting or adjusting target margins.
After completion of study treatment, patients are followed up periodically.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorRaymond H. Mak