NCT03321045EARLY_PHASE1Recruiting
Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
University of Alabama at Birmingham
Start Date
11/21/2017
Completion Date
10/1/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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:
* 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)
Interventions
DRUG
[89Zr]-Df-Trastuzumab
DIAGNOSTIC_TEST
PET/MRI Imaging
Conditions
Breast Cancer
Locations
The Kirklin Clinic
Birmingham, Alabama 35249
United States