OOPS: Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal Adenocarcinoma

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04834596

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Detection of Liver Metastases	Other: retrospectives analysis on hepatic scanner

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal

Anticipated Study Start Date :

May 2, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

May 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
patients without hepatic metastases hepatic scanner of 100 patients with colorectal cancer without hepatic metastases will be analysed	Other: retrospectives analysis on hepatic scanner hepatic scanner will be analysed by two radiologist and by the software
patients with synchronous hepatic metastases hepatic scanner of 100 patients with colorectal cancer with synchronous hepatic metastases will be analysed	Other: retrospectives analysis on hepatic scanner hepatic scanner will be analysed by two radiologist and by the software
patients with metachronous hepatic metastases hepatic scanner of 100 patients with colorectal cancer with metachronous hepatic metastases will be analysed	Other: retrospectives analysis on hepatic scanner hepatic scanner will be analysed by two radiologist and by the software

Arm

Intervention/Treatment

patients without hepatic metastases

hepatic scanner of 100 patients with colorectal cancer without hepatic metastases will be analysed

Other: retrospectives analysis on hepatic scanner

hepatic scanner will be analysed by two radiologist and by the software

patients with synchronous hepatic metastases

hepatic scanner of 100 patients with colorectal cancer with synchronous hepatic metastases will be analysed

Other: retrospectives analysis on hepatic scanner

hepatic scanner will be analysed by two radiologist and by the software

patients with metachronous hepatic metastases

hepatic scanner of 100 patients with colorectal cancer with metachronous hepatic metastases will be analysed

Other: retrospectives analysis on hepatic scanner

hepatic scanner will be analysed by two radiologist and by the software

Outcome Measures

Primary Outcome Measures

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. [1 month]
Number of nodules detected by the software compared to the reference method

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHAngers	Angers		France	49933

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT04834596

Other Study ID Numbers:

2021 OOPS

First Posted:

Apr 8, 2021

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Apr 8, 2021