Clinical Validation of the M5L Lung CAD

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03179150

Enrollment

237

Registered

2017-06-07

Start date

2015-09-01

Completion date

2017-06-01

Last updated

2017-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Metastatic

Keywords

computer-aided diagnosis, Web, Cloud computing, lung cancer

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.

Interventions

DIAGNOSTIC_TESTComputed 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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Diagnosed extra-thoracic neoplasm

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Comparison of reading time between unassisted vs CAD assisted reading	1 month after collection of data

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026