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Brief Title: 99mTc-ADAPT6-based HER2 Imaging in Breast Cancer
Official Title: SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6
Study ID: NCT03991260
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
TomskNRMC, Tomsk, , Russian Federation
Name: Vladimir I Chernov, MD, Prof.
Affiliation: TomskNMRC
Role: PRINCIPAL_INVESTIGATOR