Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3

Phase 1 Completed 30 enrolled Tomsk National Research Medical Center of the Russian Academy of Sciences Institute of Bioorganic Chemistry, Russian Academy of Sciences · collab Uppsala University · collab

Non-randomizedParallel-groupSingle-blindDiagnostic

Summary

The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time; 2. To evaluate dosimetry of 99mTc-HE3-G3; 3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection: The secondary objective are: 1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples.

Timeline

Start: 2020-02-10
Primary completion: 2021-02-10
Completion: 2021-10-04

Publications

Bragina O, Chernov V, Schulga A, Konovalova E, Garbukov E, Vorobyeva A, Orlova A, Tashireva L, Sorensen J, Zelchan R, Medvedeva A, Deyev S, Tolmachev V. Phase I Trial of 99mTc-(HE)3-G3, a DARPin-Based Probe for Imaging of HER2 Expression in Breast Cancer. J Nucl Med. 2022 Apr;63(4):528-535. doi: 10.2967/jnumed.121.262542. Epub 2021 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	99mTc-HE3-G3	Protein / enzyme biologic	1000 ug	Intravenous
Subject	99mTc-HE3-G3	Protein / enzyme biologic	2000 ug	Intravenous
Subject	99mTc-HE3-G3	Protein / enzyme biologic	3000 ug	Intravenous

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3

Summary

Timeline

Publications

Drugs

Indications