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

NCT06514248 | Completed

• 1 other identifier: 23-806
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Comparing the Detection Accuracy, Sensitivity, and Specificity of Clinically Actionable Lung Nodules

  The detection rates in accuracy, sensitivity, and specificity on clinically actionable lung nodules were computed and compared for Aim 1 (baseline) and Arm 2 (study participants were aided with V5med Lung AI) studies.

  6 months

• Comparing LROC Curve in the Detection of Clinically Actionable Lung Nodules Among Normal

  The areas under location-specific Receiver Operating Characteristic (LROC) curves were computed and compared for Aim 1 (baseline) and Aim 2 (study participants were aided with V5med Lung AI).

  6 months

Secondary Outcomes (1)

• Average Reading Time Per Case

  4 months

Study Arms (2)

Reader Study without AI (Baseline )

NO INTERVENTION

During the baseline reading session the radiologist will mark each location of qualified nodules and assign a score. If at least one suspicious nodule is observed, the radiologist will also indicate a Lung-RADS score (i.e., 2, 3, 4A, 4B, or 4X) at the end of case interpretation.

Reader Study with AI (Aided by V5med Lung AI)

ACTIVE COMPARATOR

Perform another reader study using the V5med Lung AI as the aided read. The reader is asked to mark all potential nodules not less than 4mm assisted by V5med Lung AI. Some or majority of ROIs' parameters will be pre-filled by V5med Lung AI. The reader will make final determination for each location. The marked location, LOS score, Lung-RADS score, and time spent will be recorded for the statistical analyses and compared to the first arm study.

Device: V5med Lung AI

Interventions

V5med Lung AI DEVICE

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.

Reader Study with AI (Aided by V5med Lung AI)

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening chest CT taken of asymptomatic patients age 55 - 77 with history of smoking
• Non-screening chest CT of an adult (age 18 and older) without comorbidity
• Primary Lung Cancer, Biopsy-proven with radiology report
• \<= 2.5mm slice spacing, no gaps
• Standard reconstruction kernels
• Maximum of 7 lung nodules per CT scan
• Nodules must be 4-30mm in size (though majority of them will be 20mm or smaller)

You may not qualify if:

• Acute pneumothorax
• Excessive motion artifacts or beam-hardening artifacts
• Symptomatic patients with co-morbidities

Sponsors & Collaborators

• V5med Inc.: lead

Study Sites (1)

Arlington Innovation Center: Health Research

Arlington, Virginia, 22203, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 23, 2024
• Study Start: December 18, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (1)