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

NCT ID: NCT03321045

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2027-10-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[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.

Group Type: EXPERIMENTAL

[89Zr]-Df-Trastuzumab

Intervention Type: DRUG

\[89Zr\]-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.

PET/MRI Imaging

Intervention Type: DIAGNOSTIC_TEST

5-6 days post injection the patients will undergo PET/MRI imaging.

Interventions

[89Zr]-Df-Trastuzumab

\[89Zr\]-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.

Intervention Type: DRUG

PET/MRI Imaging

5-6 days post injection the patients will undergo PET/MRI imaging.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Suzanne E. Lapi, PhD

Associate Professor of Radiology and Director, Cyclotron Facility

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne E Lapi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

The Kirklin Clinic

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Denise Jeffers, PharmD

Role: CONTACT

charlottejeffers@uabmc.edu

205-975-6469

Sebastian Eady, BS

Role: CONTACT

smeady@uabmc.edu

2059962636

Other Identifiers

IRB-170220004

Identifier Type: -

Identifier Source: org_study_id