NCT03321045

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1 breast-cancer

Timeline
29mo left

Started Nov 2017

Longer than P75 for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Nov 2017Oct 2028

First Submitted

Initial submission to the registry

October 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

10.9 years

First QC Date

October 19, 2017

Last Update Submit

January 23, 2026

Conditions

Breast Cancer

Keywords

89Zr-Trastuzumab, HER2 Imaging

Outcome Measures

Primary Outcomes (1)

  • Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent

    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

Study Arms (1)

[89Zr]-Df-Trastuzumab

EXPERIMENTAL

\[89Zr\]-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-TrastuzumabDiagnostic Test: PET/MRI Imaging

Interventions

PET/MRI ImagingDIAGNOSTIC_TEST

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

[89Zr]-Df-Trastuzumab
[89Zr]-Df-TrastuzumabDRUG

\[89Zr\]-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.

[89Zr]-Df-Trastuzumab

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Kirklin Clinic

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Suzanne E Lapi, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Jeffers, PharmD

CONTACT

205-975-6469charlottejeffers@uabmc.edu

Sebastian Eady, BS

CONTACT

2059962636smeady@uabmc.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology and Director, Cyclotron Facility

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 25, 2017

Study Start

November 21, 2017

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

US(1)