Magnetic Resonance Imaging in Radiotherapy for Breast Cancer

Breast Cancer Clinical Trial

— MIRROR  

Official title:

Magnetic Resonance Imaging in RadiotheRapy fOr bReast Cancer (MIRROR): A Pilot Study of MRI Simulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902507
• Other study ID #: 22725
• Secondary ID: NCI-2023-03214
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Luchia Andemicael
• Phone: 877-827-3222
• Email: Luchia.Andemicael[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging Simulation
Radiographic Image Simulation

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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)