PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    10
  • sponsor
    University of Alabama at Birmingham
Updated on 11 May 2021
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, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment [89Zr]-Df-Trastuzumab, PET/MRI Imaging
Clinical Study IdentifierNCT03321045
SponsorUniversity of Alabama at Birmingham
Last Modified on11 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult female patients (n=10) with biopsy-proven HER2-positive, with at least one FDG positive lesion by PERCIST
Be at least 18 years of age
Patients eligible for neoadjuvant therapy using a regimen containing at least one anti-HER2 agent (stage 2 and 3 HER2+ breast cancer)
ECOG performance status of 0 and 1
Ejection fraction greater than 50% by echocardiogram or MUGA scans
Be enrolled in the I-SPY 2 trial

Exclusion Criteria

Pregnant women and patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or unable to tolerate up to 60 min of PET imaging per imaging session
Inability to provide informed consent
Weight over 350 lbs., due to the scanner bore size
Contraindication for MRI study (non-removable metal implants or certain tattoos)
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