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

Launched by V5MED INC. · Jul 21, 2024

Keywords

ClinConnect Summary

Overview of the Study:

A reader study with sixteen participating radiologists will be conducted. A location-specific receiver operating characteristic (LROC) curve will be used to evaluate radiologists' detection performance in detecting qualified lung nodules on chest CT scans with and without the use of the V5med Lung AI system. The reading time for each case will also be recorded.

The 16 study radiologists will be split into two groups, X and Y. The 350 chest CT scans will be split into two subsets, A and B. Group X radiologists will interpret subset A without AI and subset B with V5me...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Screening chest CT taken of asymptomatic patients age 55 - 77 with history of smoking
• • 2. Non-screening chest CT of an adult (age 18 and older) without comorbidity
• • 3. Primary Lung Cancer, Biopsy-proven with radiology report
• • 4. \<= 2.5mm slice spacing, no gaps
• • 5. Standard reconstruction kernels
• • 6. Maximum of 7 lung nodules per CT scan
• • 7. Nodules must be 4-30mm in size (though majority of them will be 20mm or smaller)
• Exclusion Criteria:
• • 1. Acute pneumothorax
• • 2. Incomplete inclusion of both lungs, within the field of view, including both Apices
• • 3. Excessive motion artifacts or beam-hardening artifacts
• • 4. Symptomatic patients with co-morbidities