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:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
NCT ID:
NCT01858116
Brief Summary:
The study will evaluate \[68Ga\]ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer.
Detailed Description:
Open-labeled, exploratory, single center study.
1. Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four subjects with HER2-negative status. \[68Ga\]ABY-025 PET with low dose (100 μg) of ABY-025 peptide is performed, followed by a repeated PET within three weeks using high dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third \[68Ga\]ABY-025 PET will be performed in the HER2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the ABY-025 peptide dose previously determined to be preferable.
2. Group 2 Ten subjects with HER2-positive primary tumor status. \[68Ga\]ABY-025 PET is performed using the ABY-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second \[68Ga\]ABY-025 PET investigation at signs of progressive disease or else latest after 9 months.
Study:
NCT01858116
Study Brief:
Protocol Section:
NCT01858116