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

HER2-positive Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109977
• Other study ID #: 17-059
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2017
• Last updated: April 16, 2018
• Start date: March 31, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: April 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HER2-positive Carcinoma
• HER2-positive Primary Malignancy
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Slaon-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center