NCT05203497

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	SPECT	One single injection of 99mTc-ZHER2:41071, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Timeline

• Start date: 2021-12-22
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-01-24
• Last updated: 2023-04-21

Locations

1 site across 1 country: Russia