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

Early Phase 1

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: [89Zr]-Df-Trastuzumab; Diagnostic Test: PET/MRI Imaging

• Registration Number: NCT03321045
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-25
• Study Start: 2017-11-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[89Zr]-Df-Trastuzumab	PET/MRI Imaging	\[89Zr\]-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.
[89Zr]-Df-Trastuzumab	[89Zr]-Df-Trastuzumab	\[89Zr\]-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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Kirklin Clinic; 🇺🇸 Birmingham, Alabama, United States