Performance Study for InferRead CT Pneumonia.AI

Pneumonia Clinical Trial

Official title:

Performance Study for InferRead CT Pneumonia.AI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04955704
• Other study ID #: PNEUMONIA06142021
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: June 2021
• Source: Infervision
• Contact: Frank Wu
• Phone: 8579981888
• Email: frank.wu[@]infervision.ai
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 423
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Device:
• InferRead CT Pneumonia.AI
InferRead CT Pneumonia.AI reads chest CT DICOM images from medical imaging storage devices and triages cases by detecting pneumonia lesions and then flagging suspected cases in the study list. InferRead CT Pneumonia.AI is a tool to assist clinicians and it does not replace the interpretation and diagnosis by clinicians.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Infervision	University of Maryland, College Park

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	The Sensitivity (SE) of InferRead CT Pneumonia.AI is higher than 0.80. H0: YSE = 0.80 HA: YSE > 0.80; The Specificity (SP) of InferRead CT Pneumonia.AI is higher than 0.80. H0: YSP = 0.80 HA: YSP > 0.80	1/1/2022 - 2/28/2022
Secondary	Secondary Endpoint	The Average Per Case Processing Time of InferRead CT Pneumonia.AI is lower than Time-to-open-exam in the standard of care; H0: Per Case Processing Time = Time-to-open-exam HA: Per Case Processing Time < Time-to-open-exam; The Average Per Case Processing Time of InferRead CT Pneumonia.AI includes the time to receive the DICOM exam and the shows AI results on the studylist. The standard of care time-to-open-exam is defined as the time from the initial scan of the patient to the time when the radiologist first opens the exam for review.	1/1/2022 - 2/28/2022