Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2

Summary

The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer The primary objectives are: 1. To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time; 2. To evaluate dosimetry of 99mTc-ZHER2:41071; 3. To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection: The secondary objectives are: 1\. To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.

Timeline

Start

2021-12-22

Primary completion

2023-03-01

Completion

2023-03-01

Drugs

Indications