NCT06514248Completed
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 · Last updated 23 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 5 Jul 2024
- Start date
- 18 Dec 2023
- Primary completion date
- 17 May 2024
- Lead sponsor
- V5med Inc.
- Diseases
- Lung cancer
- NCT number
- NCT06514248
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 18 Dec 2023 to the primary completion date, 17 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Acute pneumothorax
- Incomplete inclusion of both lungs, within the field of view, including both Apices
- Excessive motion artifacts or beam-hardening artifacts
- Symptomatic patients with co-morbidities
Who the study is looking for
- 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)
Age in the registry: 55 years to 77 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arlington Innovation Center: Health Research Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.