Evaluating the Real World Performance of an AI Based Lung Nodule Detection Tool
ConditionLung Nodule
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
chest x-rays will be analyzed by AI software for a secondary read of lung nodules. Chest x-rays will either be sent to the AI tool to be read or to radiologists to read. If the image is sent to the AI tool, the AI software will generate a report on if it detects a lung nodule or not. The image will then be sent to a radiologist to determine if there is agreement or disagreement with the AI tool.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chest X-ray images of patients aged 18 - 89 years.
Modality: CR/DR/DX.
PA/view
Lung nodules measuring 6 mm -30 mm (for chest X-ray images where presence of nodules is required).
Disqualifiers
Incomplete view of the chest.
Lateral view
Known lung cancer at the time of Chest x-ray images.
Trial population
Chest x-rays collected on patients aged 18-89
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AI Based CAD Software (qXR-Ln)
DeviceAll x-ray images have already been obtained and will then be run through CAD software for secondary nodule detection
Treatment groups
45,991 Participants
are divided into 2 treatment groupsGroup A: Image going through AI tool1 intervention
Group B: image not going through AI tool0 interventions
Trial outcomes
Primary outcomes
1
number of patients with actionable lung nodule as measured by CT scan
Time frame
up to one year2
total number of patients having chest x-ray
Time frame
up to one year3
number of patients with high risk lung nodule as measured by CT scan
Time frame
up to one year4
total number of patients referred for a CT scan
Time frame
up to one yearSponsors and contacts
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Source ClinicalTrials.gov