Evaluation of Computer-Aided Lung Nodule Detection Software in Thoracic CT for Riverain Technologies LLC

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.

Conditions

• Lung Cancer

Interventions

DEVICE

ClearRead CT Insight

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).

Sponsors & Collaborators

• Riverain Technologies

  collaborator INDUSTRY

• Virginia Polytechnic Institute and State University

  lead OTHER

Principal Investigators

• Matthew T Freedman, M.D. · Virginia Polytechnic Institute and State University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

77 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2017-09-30

Completion

2018-03-31

Countries

• United States

Study Locations