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Completed

NCT Number: NCT03179150

Clinical Validation of the M5L Lung CAD

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.

Completed

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Key information

Conditions

Lung Cancer Metastatic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Candiolo

Candiolo, Torino, 10060, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed extra-thoracic neoplasm

Exclusion criteria

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

Treatment and study plan

Computed Tomography

Diagnostic Test

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

Primary outcomes

  1. Per-patient detection sensitivity unassisted vs CAD assisted reading

    Time frame: 1 month after collection of data

    Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis

  2. Per-lesion detection sensitivity unassisted vs CAD assisted reading

    Time frame: 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 outcomes

  1. Comparison of reading time between unassisted vs CAD assisted reading

    Time frame: 1 month after collection of data

Sponsors and collaborators

Lead sponsor

Candiolo Cancer Institute - IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 7, 2017
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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