Monitoring Triple Negative Breast Cancer Immunotherapy with Advanced PET/MRI

This study is looking at how well a special type of imaging, called [18F]FMISO-PET with contrast-enhanced MRI, can monitor and predict the effects of immunotherapy in people with triple negative breast cancer (stages II-IV). Researchers want to see if this imaging can help understand how immunotherapy is working. You might be able to join if you are a woman between 18 and 75 years old, have biopsy-proven triple negative breast cancer (stage II-IV), and are planning to start immunotherapy. You must also have more than 50% PD-L1 (a protein on cancer cells) positive. This study will enroll 20 patients and will not change your treatment plan, which will be decided by your oncologist. The main goal is to measure certain values from the PET and MRI scans at the beginning of the study.

Study design
This is an interventional study with 20 participants. It is a parallel imaging study, meaning it runs alongside your regular treatment.
What's involved
You will have a pre-study visit for consent, vital signs, blood tests, and an MRI fit test. You will then have up to three imaging visits, with the first one before you start immunotherapy.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04861077

Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)

Recruiting
EARLY_PHASE1Ages 18–75InterventionalDiagnostic
University of Alabama at Birmingham
~20 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:[18F]FMISO-PET with contrast-enhanced MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline measure of PET standardized uptake value (SUV).
Measured over Baseline
+1 more outcome measured
Triple Negative Breast Cancer
1 sites across 1 states
Alabama1
  • Janis O'Malley, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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  • Baseline measure of PET standardized uptake value (SUV).Baseline

    Compare baseline metrics from PET/MRI

  • Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.Baseline

    Compare baseline metrics from PET/MRI.