NCT05902507Recruiting
Magnetic Resonance Imaging in Radiotherapy for Breast Cancer
University of California, San Francisco
Start Date
5/15/2023
Completion Date
5/31/2027
Summary
This is a single-center, prospective pilot study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatment (RT) for breast cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To determine feasibility of acquiring MRI simulation prior to RT planning. EXPLORATORY OBJECTIVE: I. To determine change in target volume with MRI simulation compared to Computerized tomography (CT) simulation. OUTLINE: MRI simulation will be performed once at baseline. There is no follow up planned for study purposes. Patients will be followed as part of their regular clinical care.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Participants with an Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (or Karnofsky ≥\>=60%, see Appendix A).
2. Participants with the ability to understand and the willingness to sign a written informed consent document.
3. Participants may separately enroll on therapeutic clinical trials when they enroll on this trial. Note: All interventions on this protocol are standard of care, so enrollment on other therapeutic protocols is allowed at the discretion of the treating physician.
4. Patients must have pathologically confirmed invasive or in situ breast cancer.
5. Patients must have tumors in which adjuvant breast radiotherapy following breast conserving surgery is indicated, as determined by the treating physician.
6. Patients must be female. Note: Male patients are excluded due to the rarity of male breast cancer and difficulty in pursuing breast conserving surgery for male patients.
Exclusion Criteria:
1. Participants with a contraindication to MRI per the MRI checklist.
2. Patients with breast tumor or tumor bed not visualized at CT or MRI during RT planning.
Interventions
DIAGNOSTIC_TEST
Magnetic Resonance Imaging Simulation
Conditions
Breast Cancer
Locations
University of California, San Francisco
San Francisco, California 94143
United States