At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Computer-Aided System for the Improvement of Nodule Detection and Characterization in Thoracic CT Based on a Novel Vessel Suppressed CT Volume
In Brief
A clinical study evaluating ClearRead CT Insight for Lung Cancer. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
During the second reading session (concurrent read), the radiologist will be presented with a standard appearing CT with CADe marks placed and the vessel suppressed same slice with the vessel suppressed view as the intervention. The second image, vessel suppressed, will be grayed out until the radiologist move the mouse to the second panel. The radiologist will mark locations. These may or may not correspond to the locations of the CAD markers. As before, the radiologist will assign a level of suspicious to each mark and indicate the need, if any, of an additional diagnostic action (CT Follow-up, Contrast CT, PET-CT, or Biopsy).