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Recruiting NCT05902507

Magnetic Resonance Imaging in Radiotherapy for Breast Cancer

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Imaging Simulation.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test Magnetic Resonance Imaging Simulation
    Radiographic Image Simulation

Primary outcome measures

  • Percentage of participants who completed scan [Time frame: Day of MR imaging (1 day)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT05902507 · 22725 · NCI-2023-03214

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗