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

The University of Alabama at Birmingham

Status and phase: Enrolling; Early Phase 1

Conditions: Breast Cancer

Treatments: Diagnostic Test: PET/MRI Imaging; Drug: [89Zr]-Df-Trastuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03321045

IRB-170220004

UAB (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

[89Zr]-Df-Trastuzumab

Experimental group

Description:

\[89Zr\]-Df-Trastuzumab \[89Zr\]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 millicurie (mCi) at the time of injection. The amount of injected drug is 5 mg of Trastuzumab. 5-6 days post injection the patients will undergo PET/MRI imaging.

Treatment:

Drug: [89Zr]-Df-Trastuzumab

Diagnostic Test: PET/MRI Imaging