Clinical trial · Interventional
Clinical Evaluation of the V5-LU01 AI Software in Thoracic CT for V5med Inc.
Evaluation of V5 Lung AI Software With A Two-Arm Comparative Reader Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| V5med Lung AI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Reader Study without AI (Baseline )
- description
- 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.
- type
- ACTIVE_COMPARATOR
- label
- Reader Study with AI (Aided by V5med Lung AI)
- description
- 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.
- interventionNames
- Device: V5med Lung AI
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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
References
Publications (0)
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