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NCT03179150 Clinical Trial

Clinical Validation of the M5L Lung CAD

Lung Cancer Metastatic Clinical Trial

Official title:
Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03179150
Other study ID # 35/2017 CADM5L
Secondary ID
Status Completed
Phase N/A
First received June 6, 2017
Last updated June 6, 2017
Start date September 1, 2015
Est. completion date June 1, 2017

Study information
Verified date June 2017
Source Candiolo Cancer Institute - IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 237
Est. completion date June 1, 2017
Est. primary completion date March 30, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Computed Tomography
CT scans were performed on a 128 detector rows CT scanner (Somatom Definition Flash Siemens Medical Systems, Erlangen, Germany) as in routine clinical practice in the centre

Locations
Country Name City State
Italy IRCCS Candiolo Candiolo Torino

Sponsors (1)
Lead Sponsor Collaborator
Candiolo Cancer Institute - IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Per-patient detection sensitivity unassisted vs CAD assisted reading Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis 1 month after collection of data
Primary Per-lesion detection sensitivity unassisted vs CAD assisted reading 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 1 month after collection of data
Secondary Comparison of reading time between unassisted vs CAD assisted reading 1 month after collection of data
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