Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03321045

Positron Emission Tomography (PET) Imaging With Zirconium-89 (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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

The Kirklin Clinic

Birmingham, Alabama, 35249, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

[89Zr]-Df-Trastuzumab

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

Diagnostic Test

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Jeffers, PharmD

CONTACT

[email protected]

205-975-6469

Sebastian Eady, BS

CONTACT

[email protected]

2059962636

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Oct 25, 2017
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.