NCT05695859

99mTc-DARPinG3 SPECT/CT for Non-invasive HER2-AX in Breast Cancer With Metastatic Lymph Nodes Before Targeted Therapy

SPECT/CT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Primary Tumour and Metastatic Axillary Lymph Nodes Using Technetium-99m-labelled DARPinG3 Molecule-based.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (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

An open-label, single center study with 99mTc-DARPinG3 SPECT/CT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPinG3 SPECT/CT and standard histopathology from relevant tumor and lymph node biopsies.

Detailed description

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before chemo/targeted therapy.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	99mTc-DARPinG3 SPECT/CT	One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection

Timeline

• Start date: 2022-12-20
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-01-25
• Last updated: 2024-03-01

Locations

1 site across 1 country: Russia