Lung Cancer Metastatic Clinical Trial
Official title:
Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L
Verified date | June 2017 |
Source | Candiolo Cancer Institute - IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Candiolo | Candiolo | Torino |
Lead Sponsor | Collaborator |
---|---|
Candiolo Cancer Institute - IRCCS |
Italy,
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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