PneumoniaNCT04955704
Performance Study for InferRead CT Pneumonia.AI
An observational study of Pneumonia, run by Infervision.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- InferRead CT Pneumonia.AI
- Type of treatment
- Medical device
- How many people
- 423 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This retrospective study will be used to assess the performance of the subject device. The principal investigator will collect DICOM data and relevant clinical information based on the selection criteria. DICOM will be de-identified of PHI and stored in a secure location. The validation dataset will contain non-contrast chest CT scans from patients in the United States that are either negative or have confirmed pneumonia (viral or bacterial). Data will come from at least 3 hospitals and cover a variety of data attributes.
Who may be able to join
- Non-contrast chest CT DICOM scans
- Contains both lung lobes
- Slice thickness is less than 3 mm.
Who cannot join
- Incomplete scan or corrupted scan
- Irregular scanning, increased intrapulmonary density due to insufficient inspiration, and respiratory artifacts affecting the physician's judgment.
- Altered or absent lung morphology in the postoperative patient.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- To evaluate the performance of InferRead CT Pneumonia.AI.
- 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
- Conditions
- Pneumonia
- Being tested
- InferRead CT Pneumonia.AI
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InferRead CT Pneumonia.AIDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1/1/2022 - 2/28/2022
Secondary outcomes (1)
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.
Measured: 1/1/2022 - 2/28/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 423 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infervision
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, College Park
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955704
- Sponsor's protocol ID
- PNEUMONIA06142021
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Study for InferRead CT Pneumonia.AI
- ClinicalTrials.gov ID
- NCT04955704
- Acronym / sponsor ID
- PNEUMONIA06142021
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 423 participants (estimated)
- Lead sponsor
- InfervisionIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, College Park
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- To evaluate the performance of InferRead CT Pneumonia.AI.
- 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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will be used to assess the performance of the subject device. The principal investigator will collect DICOM data and relevant clinical information based on the selection criteria. DICOM will be de-identified of PHI and stored in a secure location. The validation dataset will contain non-contrast chest CT scans from patients in the United States that are either negative or have confirmed pneumonia (viral or bacterial). Data will come from at least 3 hospitals and cover a variety of data attributes.
Key inclusion criteria (3 listed)
- Non-contrast chest CT DICOM scans
- Contains both lung lobes
- Slice thickness is less than 3 mm.
Key exclusion criteria (3 listed)
- Incomplete scan or corrupted scan
- Irregular scanning, increased intrapulmonary density due to insufficient inspiration, and respiratory artifacts affecting the physician's judgment.
- Altered or absent lung morphology in the postoperative patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InferRead CT Pneumonia.AIInferRead 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. | Device | – |
Primary outcome
Primary Endpoint
Time frame: 1/1/2022 - 2/28/2022
1. The Sensitivity (SE) of InferRead CT Pneumonia.AI is higher than 0.80. H0: YSE ≤ 0.80 HA: YSE > 0.80 2. The Specificity (SP) of InferRead CT Pneumonia.AI is higher than 0.80. H0: YSP ≤ 0.80 HA: YSP > 0.80
1 secondary outcome
Secondary Endpoint
Time frame: 1/1/2022 - 2/28/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Infervision.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Wu (8579981888, frank.wu@infervision.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 1/1/2022 - 2/28/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.