Completed

NCT Number: NCT03109977

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

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.

Completed

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Key information

Conditions

HER2-positive Carcinoma HER2-positive Primary Malignancy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Slaon-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zr-DFO-pertuzumab PET/CT

Drug

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

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Apr 12, 2017
Registry last updated: Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.