HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011 - Trial NCT06369831
Access comprehensive clinical trial information for NCT06369831 through Pure Global AI's free database. This Phase 2 trial is sponsored by ABSCINT NV/SA and is currently Not yet recruiting. The study focuses on Metastatic Breast Cancer. Target enrollment is 60 participants.
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Study Focus
Sponsor & Location
ABSCINT NV/SA
Timeline & Enrollment
Phase 2
Aug 01, 2024
Jun 01, 2025
Primary Outcome
positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test.
Summary
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011
 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to
 drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard
 of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization
 (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose
 F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography
 (ceCT).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06369831
Non-Device Trial