Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Diagnostic
Enrollment
240actual
Sites
27
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-21 | actual | When the study began enrolling |
| Primary completion | 2025-05-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-06 | actual | The whole study's end, after follow-up |
| First posted | 2023-08-24 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-25 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Lesion in Body Region
- CNS Lesion
Interventions
- Drug: Gadopiclenol — also filed as Elucirem/Vueway
- Drug: Comparator (gadobutrol) — also filed as Gadovist/Gadavist
Primary outcomes
what the primary-completion date above is the date OFLesion Visualization on Paired Images: Border Delineation
measured At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)
Lesion Visualization on Paired Images: Internal Morphology
measured At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)
Lesion Visualization on Paired Images: Degree of Contrast Enhancement
measured At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-10-22 · 2.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-06-26 · 698 KB · SAP_001.pdf
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