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NCT05481762

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

Completed Last updated 8 February 2023
What this trial tests

trial testing Aided read with contextflow DETECT Lung CT in Lung Cancer in 337 participants. Completed in 30 October 2022.

Timeline
1 April 2022
Primary endpoint
30 October 2022
30 October 2022

Quick facts

Lead sponsorcontextflow GmbH
StatusCompleted
Study typeOBSERVATIONAL
Enrollment337
Start date1 April 2022
Primary completion30 October 2022
Estimated completion30 October 2022
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

contextflow GmbH

Who can join

22 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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