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NCT02440139 · ClinicalTrials.gov registry record · NA
Evaluation of Computer-Aided Lung Nodule Detection Software in Thoracic CT for Riverain Technologies LLC
A NA study, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT02440139 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 12 participants.
The verdict
NCT02440139, a NA study, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
STUDY DESIGN: This is a retrospective, multi-reader, multi-case, (MRMC) randomized reader study. OBJECTIVE: Primary: The primary objective of this clinical study is to prove that a user aided with ClearRead CT InSight (CRCTI) is superior to the unaided reader for detecting actionable lung nodules. Secondary: The secondary objective of this clinical study is to prove that the reader's reading time is not significantly increased when aided with CRCTI. NUMBER OF SUBJECTS: Retrospective CT studies from approximately 300 patients will be included in the study. Approximately 100 true positive cases and 200 normal cases. NUMBER OF READERS: A reader study with at least ten (10) participating radiologists (US Board Certified) will be conducted. PRIMARY ENDPOINTS: Scores given by the radiologists with and without ClearRead CT Insight will be recorded and compared to the true status of the study-cases. The frequency of the scores for each method (Unaided, Aided) will be tabulated and LROC curves constructed along with sensitivity, specificity, PPV, NPV and clinical actions. Additionally, machine nodule detection rate and false positives per patient on normal cases will be measured. PATIENT POPULATION : The study will target approximately one hundred (100) patients whose CT nodules were shown to be cancer and two hundred (200) normal patients. The patient population will be consistent with the national lung cancer screening protocols.
Interventions
- DEVICE ClearRead CT Insight
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-04 |
| Est. Completion | 2018-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02440139
The ClinicalTrials.gov registry entry for NCT02440139 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Polytechnic Institute and State University, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ClearRead CT Insight is the first listed.
NCT02440139 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02440139 about?
NCT02440139 is a clinical study titled "Evaluation of Computer-Aided Lung Nodule Detection Software in Thoracic CT for Riverain Technologies LLC". STUDY DESIGN: This is a retrospective, multi-reader, multi-case, (MRMC) randomized reader study. OBJECTIVE: Primary: The primary objective of this clinical study is to prove that a user aided with ClearRead CT InSight (CRCTI) is superior to the unaided reader for detecting actionable lung nodules...
What is the current status of trial NCT02440139?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2015-04. Estimated completion is 2018-03.
What interventions are being tested in trial NCT02440139?
The interventions under investigation include: ClearRead CT Insight (DEVICE).
Who is sponsoring clinical trial NCT02440139?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
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