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Clinical Evaluation of the V5-LU01 AI Software in Thoracic CT for V5med Inc.

NCT06514248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-07-23

No results posted yet for this study

Summary

STUDY DESIGN:

This is a two-arm retrospective, multi-reader, multi-case, (MRMC) randomized reader study.

OBJECTIVE:

Primary: The primary objective of this clinical study is to prove that radiologist's performance aided with V5med Lung AI is superior to the unaided for detecting qualified lung nodules.

Secondary: The secondary objective of this clinical study is to prove that the radiologist's reading time is not significantly increased when aided with V5med Lung AI.

Addition Objectives: To prove that the agreement (e.g., in kappa correlation coefficient) between experts and radiologist's Lung-RADS score aided with V5med Lung AI is superior to the unaided.

NUMBER OF SUBJECTS:

Retrospective CT studies from approximately 350 patients will be included in the study with approximately 170 true positive cases and 180 normal cases.

PRIMARY ENDPOINTS:

Scores given by the radiologists with and without V5med Lung AI will be recorded and compared to the true status of the study-cases. The frequency of the scores for each method (Aided, Unaided) 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 two hundred (200) patients whose CT lung nodules were shown to be cancer and one hundred and eighty (150) patients who have no lung nodule greater than 4mm. The patient population will be consistent with the national lung cancer screening protocols.

Conditions

Interventions

DEVICE

V5med Lung AI

During the second reading session (concurrent read), the radiologist will be presented with a standard appearing CT with CADe marks placed on the "left window" and the same original without any AI mark with be display on the "right window". Deeming a nodule, the radiologist will mark location. These may or may not correspond to the locations of the CADe markers. As in the baseline study, the radiologist will assign a level of suspicious to each mark and provide a Lung-RADS score and the size of longest dimension.

Sponsors & Collaborators

  • V5med Inc.

    lead INDUSTRY

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
2023-12-18
Primary Completion
2024-05-17
Completion
2024-05-17

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514248 on ClinicalTrials.gov