Pilot study to explore the diagnostic value of gadopiclenol in pathological and radiological insights with multiparametric MRI enhancement in breast cancer.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521810-24-00

Acronym

GAPI-PRIME

Enrollment

Registered

2025-09-05

Start date

2025-09-22

Completion date

Unknown

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Brief summary

Evaluate the correlation between the multiparametric magnetic resonance imaging lesion characteristics (size, type of lesion, morphology, enhancement pattern and kinetics) and histopathological tumor parameters (size, grade, molecular subtype).

Detailed description

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.

Interventions

DRUGElucirem 0.5 mmol/mL solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Evaluate the correlation between the multiparametric magnetic resonance imaging lesion characteristics (size, type of lesion, morphology, enhancement pattern and kinetics) and histopathological tumor parameters (size, grade, molecular subtype).	—

Secondary

Measure	Time frame
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.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026