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Evaluation of Contextflow DETECT Lung CT Nodule Detection Software in Chest CT Scans

NCT05481762 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 337

Last updated 2023-02-08

No results posted yet for this study

Summary

contextflow DETECT Lung CT is a Artificial Intelligence (AI)-based computed-aided detection (CADe) system, intended to support radiologists in the detection of lung nodules in chest computed tomography (CT) scans. System is intended to be used as a second-reader, therefore results provided by the software are meant to complement the radiologist's findings and decisions.

Proposed study will be multi-reader, multi case (MRMC) retrospective reader study. The goal of the study is to evaluate the influence of CADe on the effectiveness of lung nodule detection. During the study, 10 radiologists will analyze 350 chest CT scans of adult patients, with and without the assistance of CADe. The study will be conducted remotely. CT scans will be uploaded to a web-based image submission and annotation platform, in which every participant of the study will be provided with individual account and assigned task list.

The primary objective of the study determine if the diagnostic accuracy of radiologists with CADe assistance is superior to the diagnostic accuracy of radiologists without CADe assistance in localizing the pulmonary nodules with enhanced area under the free-response operating characteristic curve (AUC of FROC).

The study will target approximately 350 asymptomatic adult patients, whose CT scans were acquired during routine CT examination. The patient population will include patients with and without lung nodules.

Conditions

Interventions

DEVICE

Aided read with contextflow DETECT Lung CT

Radiologists read chest CT scabs with and without the aid of contextflow DETECT Lung CT as a second reader

Sponsors & Collaborators

  • contextflow GmbH

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-10-30
Completion
2022-10-30

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481762 on ClinicalTrials.gov