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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT03321045
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [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.

Study Details

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.

Key Dates

Start date
Nov 21, 2017
Status verified
Jan 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Kirklin ClinicBirminghamAlabama35249-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The Kirklin Clinic· Birmingham, AL

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