Recruiting
Early Phase 1

89Zr-Trastuzumab

Sponsor:

University of Alabama at Birmingham

Code:

NCT03321045

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[89Zr]-Df-Trastuzumab

PET/MRI Imaging

Study Details

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 ID

NCT03321045

Start date

Nov 21, 2017

Status verified date

Jan, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

PET/MRI Imaging

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Denise Jeffers, PharmD

205-975-6469charlottejeffers@uabmc.edu

Sebastian Eady, BS

2059962636smeady@uabmc.edu

Locations

The Kirklin Clinic

Recruiting

Birmingham, Alabama, United States, 35249

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • 89Zr-Trastuzumab, HER2 Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-01-26.