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

Memorial Sloan Kettering Cancer Center6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

HER2-positive Carcinoma HER2-positive Primary Malignancy

Interventions

Zr-DFO-pertuzumab PET/CTDRUG

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Memorial Slaon-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0

Patients will be monitored closely for evidence of adverse events, including vital signs before and after tracer administration. The day after tracer administration, a physician will screen for any side effects requiring treatment. If a severe adverse effect (Common Terminology Criteria for Adverse Events grade 3 or 4) attributable to 89Zr-DFO-pertuzumab occurs in any patient, then further use of 89Zr-DFO-pertuzumab will be suspended and the protocol reviewed with the MSKCC Data Safety Monitoring Committee.

Time frame: 1 year

Data from ClinicalTrials.gov

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