NCT05923268

Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins ([99mTc]Tc-G3-(G3S)3C)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (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 \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer

Detailed description

Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy). Phase I. Distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	[99mTc]Tc-G3-(G3S)3C	One single injection of \[99mTc\]Tc-G3-(G3S)3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours

Timeline

• Start date: 2023-06-04
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2023-06-28
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia