NCT04692831

Testing a New Imaging Agent to Identify Cancer

Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.

Conditions

• HER-2 Positive Malignant Carcinoma of Breast
• HER-2 Protein Overexpression
• HER2-positive Metastatic Breast Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	89Zr-ss-pertuzumab PET/CT	Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.

Timeline

• Start date: 2020-11-30
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2021-01-05
• Last updated: 2025-04-20

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study