Clinical Validation of the M5L Lung CAD
Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L
1 other identifier
observational
237
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedJune 7, 2017
June 1, 2017
7 months
June 6, 2017
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Comparison of reading time between unassisted vs CAD assisted reading
1 month after collection of data
Study Arms (1)
Oncological patients with extra-thoracic cancer
Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies.
Interventions
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
Eligibility Criteria
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
You may qualify if:
- Diagnosed extra-thoracic neoplasm
You may not qualify if:
- More than 10 nodules
- Severe pulmonary fibrosis
- Diffuse bronchiectasis
- Extensive inflammatory consolidation
- Massive pleural effusion
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Candiolo
Candiolo, Torino, 10060, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 6, 2017
First Posted
June 7, 2017
Study Start
September 1, 2015
Primary Completion
March 30, 2016
Study Completion
June 1, 2017
Last Updated
June 7, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share