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Monitoring HER2-positive Breast Cancer Treatment with PET/MRI

This study is looking at whether a special imaging technique using [18F]FMISO PET/MRI can help doctors monitor and predict how well trastuzumab (Herceptin) works with chemotherapy for HER2-positive breast cancer. This study is for imaging only and does not involve new treatments. You would be eligible if you are a woman between 18 and 75 years old with HER2-positive breast cancer. The study aims to understand how these imaging results at the beginning of treatment relate to how your body responds. While this study won't change your current treatment, it could help doctors better understand and treat breast cancer in the future.

Study design
This is an interventional study planning to enroll 25 women. Your participation group depends on your doctor's treatment plan.
What's involved
If you are in cohort #1, you would have 4 visits to UAB, including a screening visit and PET/MRI scans before starting chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements are taken at baseline (before treatment starts).

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

NCT04332588

Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
University of Alabama at Birmingham
~25 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:[18F]FMISO PET/MRI imaging

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
+5 more outcomes measured

Conditions

HER2-positive Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Jonathan McConathy, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Anna Sorace, PhD
[email protected]
205-934-3116
Email the study team

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What this trial measures

  • 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

  • Baseline measure of signal enhancement ratio (SER) from MRI.Baseline

    Compare baseline metrics from PET/MRI

  • Changes in SER from MRIBaseline through 6 months

    Compare percent change of SER from imaging visit 3 to the baseline.

  • Changes in ADC from MRIBaseline through 6 months

    Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.

  • Changes in SUV from PETBaseline through 6 months

    Compare percent change of SUV from imaging visit 3 to the baseline.