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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: HER2-positive Primary Malignancy; HER2-positive Carcinoma

Treatments: Drug: Zr-DFO-pertuzumab PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03109977

17-059

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Drug: Zr-DFO-pertuzumab PET/CT