Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
Recruiting now · Early Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03321045
- Run by
- University of Alabama at Birmingham
- People needed
- 10
- Starts
- 2017-11-21
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- The Kirklin Clinic — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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