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

  • STATUS
    Recruiting
  • End date
    Jan 26, 2025
  • participants needed
    10
  • sponsor
    University of Alabama at Birmingham
Updated on 26 March 2022
immunohistochemistry
HER2
trastuzumab
adjuvant therapy
erbb2
her2/neu-positive breast cancer
mammogram

Summary

Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.

Details
Condition Breast Cancer
Treatment [89Zr]-Df-Trastuzumab, PET/MRI Imaging
Clinical Study IdentifierNCT03321045
SponsorUniversity of Alabama at Birmingham
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

Pregnancy
Inability to provide informed consent
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)
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