Spots Global Cancer Trial Database for Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3

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Trial Identification

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

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)

Study ID: NCT04277338

Conditions

Primary Breast Cancer

Interventions

SPECT

Study Description

Brief 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.

Detailed 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.