NCT05412459

99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients in Dynamic of Chemo+Targeted Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• 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-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer in dynamic of chemo+targeted therapy, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPin G3 SPECT and standard histopathology from primary tumor in dynamic of chemo+targeted therapy.

Detailed description

none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.

Conditions

• HER2-positive Breast Cancer
• Female

Interventions

Type	Name	Description
DRUG	99mTc-DARPinG3	Diagnostic test (99mTc-DARPinG3-based SPECT) is used for the assessment of the effect of anticancer therapy.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-31
• Completion: 2023-01-31
• First posted: 2022-06-09
• Last updated: 2023-03-06

Locations

2 sites across 1 country: Russia