SYFb3cdff88840e43d797412337f3ab4194Registry ID: 2025-521810-24-00|UnknownPhase 4
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interventional
N/A
1 country
1
To investigate the correlation between gadopiclenol-enhanced multiparametric magnetic resonance imaging findings with histopathological results from breast cancer surgery.
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Not reported
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June 9, 2025
Actual (reported)Evaluate the correlation between the multiparametric magnetic resonance imaging lesion characteristics (size, type of lesion, morphology, enhancement pattern and kinetics, laterality and location of primary tumor) and histopathological tumor parameters (size, grade, histological type, lymph node status, lymphovascular invasion, nodal metastases and molecular subtype).
Diagnostic accuracy of gadopiclenol in detecting and characterizing multiplicity of breast cancer lesions.
Assessment of BPE patterns (minimal, mild, moderate and marked) and their influence on lesion visibility.
Assessment of the safety profile by collecting the adverse events during the study.
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Formulated product
Elucirem 0.5 mmol/mL solution for injection
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SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Elucirem 0.5 mmol/mL solution for injection
Named ingredient: gadopiclenol
View registry recordHospital Universitario Del Vinalopo
Elche, 03293, Spain
Research Program Manager
First Submitted
June 9, 2025
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