Magnetic Resonance Imaging in Radiotherapy for Breast Cancer

Recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Magnetic Resonance Imaging Simulation

• Registration Number: NCT05902507
• Lead Sponsor: University of California, San Francisco

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.

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.

Study Timeline

• Study Start: 2023-05-15
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer Participants	Magnetic Resonance Imaging Simulation	Participants will receive both MRI and CT simulation scans.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States