The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3
Official Title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins HE3-G3 (99mTc-HE3-G3)
Study ID: NCT04277338
Brief Summary: The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time; 2. To evaluate dosimetry of 99mTc-HE3-G3; 3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection: The secondary objective are: 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-HE3-G3 in patients with primary breast cancer. The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time; 2. To evaluate dosimetry of 99mTc-HE3-G3; 3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection: The secondary objective are: 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
Affiliation: Tomsk NRMC
Role: PRINCIPAL_INVESTIGATOR