NCT04652947

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

September 9, 2020

Last Update Submit

November 26, 2020

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

MRI diagnosticDIAGNOSTIC_TEST

no intervention, patient only have MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed for hepatopathy

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

December 3, 2020

Study Start

December 7, 2016

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

December 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share