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

November 26, 2020 updated by: University Hospital, Angers
Compare diagnostic MRI performance of gadoteric acid, gadoxetic acid and P03277 for suspected CHC nodules less than 3 cm, using LIRADS criteria

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients followed for hepatopathy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 7, 2016

Primary Completion (ACTUAL)

October 26, 2017

Study Completion (ACTUAL)

October 26, 2017

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (ACTUAL)

December 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-74

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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