Imaging With a New Agent That Finds a Cancer Protein Called HER2

NCT ID: NCT03109977

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2018-04-12

Brief Summary

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The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.

Detailed Description

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Conditions

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HER2-positive Carcinoma HER2-positive Primary Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT

Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT will be performed in patients with known HER2-positive malignancy. Patients with multifocal disease, as demonstrated on cross-sectional imaging studies, will be preferentially recruited.

Group Type EXPERIMENTAL

Zr-DFO-pertuzumab PET/CT

Intervention Type DRUG

Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy

Interventions

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Zr-DFO-pertuzumab PET/CT

Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 21 years or greater
* Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate.
* At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
* ECOG performance of 0-2

Exclusion Criteria

* Life expectancy \< 3 months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Ulaner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Slaon-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-059

Identifier Type: -

Identifier Source: org_study_id

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