Clinical Validation of the M5L Lung CAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2017-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Oncological patients with extra-thoracic cancer

Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies.

Computed Tomography

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosed extra-thoracic neoplasm

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No