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

Phase 1

Completed

• Conditions: HER2-positive Carcinoma; HER2-positive Primary Malignancy
• Interventions: Drug: Zr-DFO-pertuzumab PET/CT

• Registration Number: NCT03109977
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-03-31
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Status Verified: 2018-04
• Primary Completion: 2018-04-12
• Study Completion: 2018-04-12
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT	Zr-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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0	1 year	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.

Trial Locations

Locations (1)

Memorial Slaon-Kettering Cancer Center; 🇺🇸 New York, New York, United States