Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT 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.
Study:
NCT03991260
Study Brief:
Protocol Section:
NCT03991260