Clinical Validation of the M5L Lung CAD

Completed

• Conditions: Lung Cancer Metastatic
• Interventions: Diagnostic Test: Computed Tomography

• Registration Number: NCT03179150
• Lead Sponsor: Candiolo Cancer Institute - IRCCS

Brief Summary

To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading.

Detailed Description

The main aim of this study is to compare the diagnostic performance of CAD assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. This study also aims at validating a new Web/Cloud based workflow for the use of CAD systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective CAD solution for clinical facilities.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-03-30
• Status Verified: 2017-06
• Study Completion: 2017-06-01
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Study First Posted: 2017-06-07
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Diagnosed extra-thoracic neoplasm

Exclusion Criteria

• More than 10 nodules
• Severe pulmonary fibrosis
• Diffuse bronchiectasis
• Extensive inflammatory consolidation
• Massive pleural effusion
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oncological patients with extra-thoracic cancer	Computed Tomography	Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies.

Primary Outcome Measures

Name	Time	Method
Per-patient detection sensitivity unassisted vs CAD assisted reading	1 month after collection of data	Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis
Per-lesion detection sensitivity unassisted vs CAD assisted reading	1 month after collection of data	Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per-lesion analysis. Sub-analyses per nodule tissue, nodule dimension and nodule localization are included

Secondary Outcome Measures

Name	Time	Method
Comparison of reading time between unassisted vs CAD assisted reading	1 month after collection of data

Trial Locations

Locations (1)

IRCCS Candiolo; 🇮🇹 Candiolo, Torino, Italy