Status:
COMPLETED
Clinical Evaluation of the V5-LU01 AI Software in Thoracic CT for V5med Inc.
Lead Sponsor:
V5med Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
55-77 years
Phase:
NA
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 radiologis...
Detailed Description
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 radiologis...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06514248
Start Date
December 18 2023
End Date
May 17 2024
Last Update
July 23 2024
Active Locations (1)
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1
Arlington Innovation Center: Health Research
Arlington, Virginia, United States, 22203