Breast Cancer Clinical Trial
— MIRROROfficial title:
Magnetic Resonance Imaging in RadiotheRapy fOr bReast Cancer (MIRROR): A Pilot Study of MRI Simulation
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Median absolute change in size of target | To evaluate the absolute change in size of target based on CT data, versus with MRI data, the change in volume (measured in cubic centimeters (cc)) of the target with MRI simulation will be calculated compared to CT. | Day of MR imaging (1 day) | |
Other | Median relative difference in size of target | To evaluate the relative difference in size of target based on CT data, versus with MRI data, the change in volume (measured in cubic centimeters (cc)) of the target with MRI simulation will be calculated compared to CT. | Day of MR imaging (1 day) | |
Primary | Percentage of participants who completed scan | Feasibility feasibility of acquiring MRI simulation prior to RT planning is defined as successfully acquiring MRI data at the specified time point in a participant's radiotherapy (RT) care plan | Day of MR imaging (1 day) |
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