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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652947
Recruitment Status : Completed
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Diagnostic Test: MRI diagnostic

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: MR Quality + Diagnostic Performance for CHC Diagnosis - Gadoxetic Acid, Gadoteric Acid and P03277 Comparison
Actual Study Start Date : December 7, 2016
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

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


Primary Outcome Measures :
  1. compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules [ Time Frame: 3 months ]
    the evaluation criteria will be the classification of each nodule according to the LiRADS citeria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed for hepatopathy
Criteria

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
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04652947    
Other Study ID Numbers: 2018-74
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases