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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04834596
Other study ID # 2021 OOPS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2, 2021
Est. completion date May 2, 2022

Study information

Verified date April 2021
Source University Hospital, Angers
Contact Marie Bost
Email mabost@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer


Description:

The aim of this study is to evaluate the performance of a software for liver nodule detection in patients with colorectal cancer compared to the consensus of two radiologists analysis. 300 hepatic scanners will be analysed.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date May 2, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients consecutively treated for colorectal cancer a - Availability of imaging by injected abdominal scanner including at least one portal phase - Age over 18 Exclusion Criteria: - Patients with treatment of the hepatic nodule by ablation or previous hepatic surgery - Imaging follow-up <12 months - Non-interpretable scanner (artefact, injection quality, etc.) - Patients with more than 10 liver metastases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
retrospectives analysis on hepatic scanner
hepatic scanner will be analysed by two radiologist and by the software

Locations

Country Name City State
France UHAngers Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the performance of the software for detection of hepatic nodules on CT scan of patients with colorectal cancer compared to a reference constituted by the evaluation established by two radiologists in consensus. Number of nodules detected by the software compared to the reference method 1 month