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

January 23, 2026 updated by: Suzanne E. Lapi, PhD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • The Kirklin Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [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.
Drug: [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.
Diagnostic test: PET/MRI Imaging
5-6 days post injection the patients will undergo PET/MRI imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Suzanne E Lapi, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2017

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-170220004
  • UAB (Other Identifier: UAB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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