NCT06037343

Brief Summary

New algorithms for processing CT acquisitions, based on artificial intelligence, have been reported to improve acquisition quality. Thats' why it's possible to imagine that new scan post-processing algorithms enable better detection and characterization of hepatocellular carcinoma lesions than with standard reconstructions. DLIR reconstructions could even match with MRI detection. The aim of the study is to compare the detection and characterization of hepatic lesions according to the LI-RADS classification in CT with DLIR artificial intelligence reconstruction, compared with ASIR-V reconstruction and the gold standard of MRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

August 31, 2023

Last Update Submit

February 18, 2025

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaDLIR CTASIR reconstruction

Outcome Measures

Primary Outcomes (3)

  • Lesion size in mm

    Through study completion, an average of 1 year

  • Hypervascular appearance of lesion

    Qualitative measurement: presence or absence of hypervascular lesion

    Through study completion an average of 1 year

  • Hypervascular capsule

    Qualitative measurement : presence or absence of hypervascular capsule

    Through study completion an average of 1 year

Secondary Outcomes (1)

  • Infiltrative nature Classification of the hepatic lesion by LI-RADS in MRI

    Through study completion an average of 1 year

Eligibility Criteria

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

All adults undergoing a CT and a MRI for detection or following of an HCC during the same week

You may qualify if:

  • undergoing CT and MRI scans in the same week, with protocols dedicated to the detection of HCC lesions

You may not qualify if:

  • imaging with radiological artefact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, 5400, France

Location

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
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 14, 2023

Study Start

February 23, 2023

Primary Completion

June 23, 2023

Study Completion

December 30, 2023

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)