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

Primary Breast Cancer Clinical Trial

Official title:
SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins HE3-G3 (99mTc-HE3-G3)

Clinical Trial 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.

Clinical Trial Description

Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy. Phase I. Distribution of 99mTc-HE3-G3 in patients with primary breast cancer. 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: Methodology: Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04277338
Study type Interventional
Source Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact
Status Completed
Phase Phase 1
Start date February 10, 2020
Completion date October 4, 2021
View Details
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