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PET Imaging with Zirconium-89-Trastuzumab for HER2-Positive Breast Cancer

This study is looking at how a special imaging agent, Zirconium-89 (89Zr)-Trastuzumab, can help predict if HER2-targeted therapies will work for people with HER2-positive breast cancer. Researchers want to see if this agent, given intravenously (into a vein), can show on a PET/MRI scan how much HER2 (a protein found on some cancer cells) is in a tumor. This could help doctors understand which patients might benefit most from HER2-targeted treatments. The study plans to enroll 10 women, aged 18 or older, who have been diagnosed with HER2-positive breast cancer according to specific guidelines.

Study design
This is an interventional pilot study, meaning participants will receive a study intervention. It aims to enroll 10 women.
What's involved
You would receive an intravenous injection of [89Zr]-Df-Trastuzumab. About 5-6 days later, you would undergo a PET/MRI imaging scan.
Compensation
Not stated in the trial record.
Follow-up
The study will investigate the use of the imaging agent over 24 months.

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

NCT03321045

Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
University of Alabama at Birmingham
~10 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:[89Zr]-Df-TrastuzumabPET/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
Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
Measured over 24 months

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Suzanne E Lapi, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Denise Jeffers, PharmD
[email protected]
205-975-6469
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Be at least 18 years of age.
Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2
Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1
Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans

Exclusion

Inability to provide informed consent
Pregnancy
Inability to lie still for the imaging study
Weight over 350 lbs., due to the scanner bore size
Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)

What this trial measures

  • Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent24 months

    To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with \[89Zr\]-Df-Trastuzumab in patients with newly diagnosed breast cancer.