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NCT04652947 Clinical Trial

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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04652947
Other study ID # 2018-74
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 7, 2016
Est. completion date October 26, 2017

Study information
Verified date July 2020
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 26, 2017
Est. primary completion date October 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI diagnostic
no intervention, patient only have MRI

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Outcome
Type Measure Description Time frame Safety issue
Primary compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules the evaluation criteria will be the classification of each nodule according to the LiRADS citeria 3 months
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