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

Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal

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

Study Overview

• Status: Not yet recruiting
• Conditions: Detection of Liver Metastases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: marie bost; Email: mabost@chu-angers.fr

Study Locations

• France
  • Angers, France, 49933
    • UHAngers
    • Contact: marie bost; Email: mabost@chu-angers.fr
    • Principal Investigator: Anita Paisant

Participation Criteria

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 with colorectal cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Anticipated): May 2, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): May 2, 2022

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2021 OOPS

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