Clinical Validation of the M5L Lung CAD

June 6, 2017 updated by: Alberto Traverso, Candiolo Cancer Institute - IRCCS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Torino
      • Candiolo, Torino, Italy, 10060
        • IRCCS Candiolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Between September 2015 and March 2016, 237 consecutive patients (123 men, 52%) with an average age of 62 (range 21-90 years), were enrolled in this retrospective observational single centre study. Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month after collection of data
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
1 month after collection of data

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Candiolo Cancer Institute - IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

March 30, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35/2017 CADM5L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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