Spots Global Cancer Trial Database for Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

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Trial Identification

Brief Title: Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

Official Title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Affibody Molecule-based Tracer 99mTc-ZHER2:41071.

Study ID: NCT05203497

Conditions

Breast Cancer Female

Interventions

SPECT

Study Description

Brief 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.

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 targeted (trastuzumab or trastuzumab+pertuzumab) therapy. Phase I. Distribution of 99mTc-ZHER2:41071 in patients with primary breast cancer. The study should evaluate distribution of 99mTc-ZHER2:41071 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 tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) analysis of biopsy samples: Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.