NCT05376644

Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-ADAPT6 and 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients Before System (Chemo/Targeted) Therapy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (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-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.

Detailed description

The primary objectives are: Compare SPECT/CT imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 in HER2-positive primary tumour of breast cancer patients before system (chemo/targeted) therapy. The secondary objectives are: To compare the SPECT/CT tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	99mTc-ADAPT6	One single injection of 99mTc-ADAPT6, followed by gamma camera imaging 2 hours after injection.
DRUG	99mTc-DARPinG3	One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-31
• Completion: 2023-01-21
• First posted: 2022-05-17
• Last updated: 2023-04-25

Locations

1 site across 1 country: Russia