RecruitingEarly Phase 1NCT03321045

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

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


Sponsor

University of Alabama at Birmingham

Enrollment

10 participants

Start Date

Nov 21, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of PET scan (a whole-body imaging scan using a tracer attached to a breast cancer drug) to predict whether HER2-positive breast cancer patients — those whose tumors have a protein called HER2 that drives growth — will respond to targeted treatment before starting therapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HER2-positive breast cancer (confirmed by lab testing) - You are about to start or are currently receiving HER2-targeted therapy - You are willing to undergo the special PET scan **You may NOT be eligible if...** - Your cancer is not HER2-positive - You are pregnant or breastfeeding - You have conditions that make the scan or tracer unsafe - You have had certain previous treatments that would interfere with results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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_TESTPET/MRI Imaging

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


Locations(1)

The Kirklin Clinic

Birmingham, Alabama, United States

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NCT03321045


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