NCT05923177

Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Iodine -123-labelled Designed Ankyrin Repeat Proteins HE3-G3 ([123I] I-(HE)3-G3)

• Status: Completed
• Phase: Phase 1
• 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 \[123I\] I-(HE)3-G3 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. Phase I. Distribution of HE3-G3 (\[123I\] I-(HE)3-G3) in patients with primary breast cancer. The study should evaluate distribution of HE3-G3 (\[123I\] I-(HE)3-G3) in patients with primary HER2-positive and HER2-negative breast cancer.

Conditions

• Primary Breast Cancer

Interventions

Type	Name	Description
DRUG	SPECT	One single injection of \[123I\] I-(HE)3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-06-28
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia