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

NCT03321045 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Suzanne E Lapi, PhD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2028-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03321045 on ClinicalTrials.gov