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MR Quality + Diagnostic Performance for CHC Diagnosis - Gadoxetic Acid, Gadoteric Acid and P03277 Comparison

MR Quality + Diagnostic Performance for CHC Diagnosis - Gadoxetic Acid, Gadoteric Acid and P03277 Comparison

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04652947
Enrollment
30
Registered
2020-12-03
Start date
2016-12-07
Completion date
2017-10-26
Last updated
2020-12-03

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

Conditions

Hepatocellular Carcinoma

Brief summary

Compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules less than 3 cm, using LIRADS criteria

Interventions

DIAGNOSTIC_TESTMRI diagnostic

no intervention, patient only have MRI

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who had all three MRI scans as part of the diagnosis of the same suspected CHC lesion(s) * Reference diagnosis obtained for suspected CHC nodules by a diagnostic algorithm taking into account histology, imaging and follow-up

Exclusion criteria

* Delay between first MRI and 3rd MRI greater than 3 months

Design outcomes

Primary

MeasureTime frameDescription
compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules3 monthsthe evaluation criteria will be the classification of each nodule according to the LiRADS citeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026