MIRROR: Magnetic Resonance Imaging in Radiotherapy for Breast Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- To determine feasibility of acquiring MRI simulation prior to RT planning.
EXPLORATORY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Breast Cancer Participants Participants will receive both MRI and CT simulation scans. |
Diagnostic Test: Magnetic Resonance Imaging Simulation
Radiographic Image Simulation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants who completed scan [Day of MR imaging (1 day)]
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
Other Outcome Measures
- Median absolute change in size of target [Day of MR imaging (1 day)]
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.
- Median relative difference in size of target [Day of MR imaging (1 day)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants with an Eastern Cooperative Oncology Group (ECOG) performance status <=2 (or Karnofsky ≥>=60%, see Appendix A).
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Participants with the ability to understand and the willingness to sign a written informed consent document.
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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.
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Patients must have pathologically confirmed invasive or in situ breast cancer.
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Patients must have tumors in which adjuvant breast radiotherapy following breast conserving surgery is indicated, as determined by the treating physician.
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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:
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Participants with a contraindication to MRI per the MRI checklist.
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Patients with breast tumor or tumor bed not visualized at CT or MRI during RT planning.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Lisa Singer, MD, PhD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22725
- NCI-2023-03214