Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.
Status:
Enrolling by invitation
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences