NCT03991260

99mTc-ADAPT6-based HER2 Imaging in Breast Cancer

SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (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- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time; 2. To assess kinetics of 99mTc- ADAPT6 in blood; 3. To evaluate dosimetry of 99mTc- ADAPT6; 4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection: The secondary objective is: 1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:

Detailed description

Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy. Phase I. Distribution of 99mTc-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time; 2. To assess kinetics of 99mTc- ADAPT6 in blood; 3. To evaluate dosimetry of 99mTc- ADAPT6; 4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection: The secondary objective is: 1\. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples: Methodology: Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SPECT	One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.

Timeline

• Start date: 2019-06-05
• Primary completion: 2020-06-05
• Completion: 2020-09-05
• First posted: 2019-06-19
• Last updated: 2021-04-01

Locations

1 site across 1 country: Russia