Magnetic Resonance Imaging in Radiotherapy for Breast Cancer

NCT05902507 | Suspended

• 2 other identifiers: 22725NCI-2023-03214
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Imaging

Outcome Measures

Primary Outcomes (1)

• 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)

Other Outcomes (2)

• Median absolute change in size of target

  Day of MR imaging (1 day)

• Median relative difference in size of target

  Day of MR imaging (1 day)

Study Arms (1)

Breast Cancer Participants

Participants will receive both MRI and CT simulation scans.

Diagnostic Test: Magnetic Resonance Imaging Simulation

Interventions

Magnetic Resonance Imaging Simulation DIAGNOSTIC_TEST

Radiographic Image Simulation

Also known as: MRI

Breast Cancer Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female participants with breast cancer planning to undergo breast conserving surgery (BCS) and RT outside of this protocol.

You may qualify if:

• Participants with an Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (or Karnofsky ≥\>=60%, see Appendix A).
• Participants with the ability to understand and the willingness to sign a written informed consent document.
• 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.
• Patients must have pathologically confirmed invasive or in situ breast cancer.
• Patients must have tumors in which adjuvant breast radiotherapy following breast conserving surgery is indicated, as determined by the treating physician.
• 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.

You may not qualify if:

• Participants with a contraindication to MRI per the MRI checklist.
• Patients with breast tumor or tumor bed not visualized at CT or MRI during RT planning.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lisa Singer, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)