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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: [89Zr]-Df-Trastuzumab
* Diagnostic Test: PET/MRI Imaging


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [89Zr]-Df-Trastuzumab<br>[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. | Drug: [89Zr]-Df-Trastuzumab<br>* [89Zr]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 mCi at the time of injection. The amount of injected drug is 5 mg of Trastuzumab.<br>Diagnostic Test: PET/MRI Imaging<br>* 5-6 days post injection the patients will undergo PET/MRI imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent | To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with [89Zr]-Df-Trastuzumab in patients with newly diagnosed breast cancer. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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89Zr-Trastuzumab, HER2 Imaging