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Performance Study for InferRead CT Pneumonia.AI

I

Infervision

Status

Unknown

Conditions

Pneumonia

Treatments

Device: InferRead CT Pneumonia.AI

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04955704
PNEUMONIA06142021

Details and patient eligibility

About

A retrospective, blineded, multicenter study of the InferRead CT Pneumonia.AI to evaluate the performance in identifying non-contrast chest CT scans containing pneumonia findings.

Full description

This is a retrospective, blinded, multicenter study for the InferRead CT Pneumonia.AI. The primary endpoint will evaluate the software's performance in identifying non-contrast chest CT scans containing pneumonia. It will evaluate InferRead CT Pneumonia.AI in terms of sensitivity and specificity with respect to a ground truth, as established by trained thoracic radiologists, in the detection of penumonia. In addition, the study will compare time to notification for the InferRead CT Pneumonia.AI software with respect to the time to notification for the standard of care as established from available radiological reports.

  1. To evaluate the performance of InferRead CT Pneumonia.AI.
  2. To evaluate the effect of different factors such as CT manufacturer, CT scanning protocols and patient characteristics on the performance of InferRead CT Pneumonia.AI

Enrollment

423 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Non-contrast chest CT DICOM scans
  2. Contains both lung lobes
  3. Slice thickness is less than 3 mm.

Exclusion criteria

  1. Incomplete scan or corrupted scan
  2. Irregular scanning, increased intrapulmonary density due to insufficient inspiration, and respiratory artifacts affecting the physician's judgment.
  3. Altered or absent lung morphology in the postoperative patient.

Trial contacts and locations

0

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Central trial contact

Frank Wu

Data sourced from clinicaltrials.gov

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