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NCT06369831Not yet recruiting

HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011

Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) Targeted Positron Emission Tomography and Computed Tomography (PET/CT) With 68Ga-ABS011 in Metastatic Breast Cancer (mBC)
ABSCINT NV/SAPhase 2ClinicalTrials.govdiagnostic test
Verified
Study focus
Disease/Condition
Metastatic Breast Cancer
Drug/Device/Intervention
68Ga-NOTA-ABSCINT-HER2 PET/CT
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
ABSCINT NV/SA
Location
Aalst,Brussels,Brussels,Brussels,Brussels, Belgium
Timeline & enrollment
Phase
Phase 2
Start date
Aug 01, 2024
End date
Jun 01, 2025
Enrollment
60 participants
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
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedMalignant neoplasm: Central portion of breastMalignant neoplasm: Overlapping lesion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06369831
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.