Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-04-23 @ 8:44 AM
Study NCT ID:
NCT03179150
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of the M5L Lung CAD
Sponsor:
Candiolo Cancer Institute - IRCCS
Organization:
Study Overview
Official Title:
Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: