Magnetic Resonance Imaging in Radiotherapy for Breast Cancer (MIRROR)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging Simulation

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Catherine Lu Dugan; Phone Number: 877-827-3222; Email: catherine.ludugan@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Phone Number: 877-827-3222; Email: cancertrials@ucsf.edu
      • Contact: Catherine Lu Dugan; Email: catherine.ludugan@ucsf.edu
      • Principal Investigator: Lisa Singer, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Lisa Singer, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 22725; NCI-2023-03214 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No