Checklist for AI in Medical Imaging (CLAIM) Consensus Panel | NCT05984082

Studies
Checklist for AI in Medical Imaging (CLAIM) Consensus Panel

NCT05984082

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Sep 23, 2024Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Artificial Intelligence
Machine Learning
Diagnostic Imaging

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

May 1, 2024Actual

First Submitted Date

Aug 1, 2023

First Submission Date that Met QC Criteria

Aug 1, 2023

First Posted Date

Aug 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2024

Last Update Posted Date

Sep 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Charles E. Kahn, Jr., MD, MS, Professor and Vice Chair of Radiology, University of PennsylvaniaPrincipal Investigator

Lead Sponsor

University of PennsylvaniaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will revise the Checklist for AI in Medical Imaging (CLAIM) guideline using Delphi consensus methods. An international panel of physicians, researchers, and journal editors with expertise in AI in medical imaging -- including radiology, pathology, dermatology, GI endoscopy, and ophthalmology -- will complete up to 3 web-based surveys. Participants who complete all survey rounds will be credited as contributors on resulting publications.

Detailed Description

The survey will be administered in collaboration with:

Anthony A. Gatti, PhD (Stanford University)
Michail E. Klontzas, MD, PhD (University of Crete School of Medicine) *
Linda Moy, MD (New York University Grossman School of Medicine)
John Mongan, MD, PhD (University of California San Francisco)
Seong Ho Park, MD, PhD (University of Ulsan College of Medicine)
Ali S. Tejani, MD (University of Texas Southwestern Medical School)

(*) Survey administrator

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Revise the Checklist for AI in Medicine Imaging (CLAIM) guideline	potential revision of the CLAIM guidelines through Delphi consensus process.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

More than 70 invited panelists -- physicians, AI researchers, and journal editors -- have agreed to participate in the surveys. Those who participate in all rounds of the survey will be named as contributors in any resulting publications

Exclusion Criteria:

Non physicians, AI researchers and journal editors

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Physicians, AI researchers and journal editors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles E. Kahn, Jr., MD, MS	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38809149	Result	Tejani AS, Klontzas ME, Gatti AA, Mongan JT, Moy L, Park SH, Kahn CE Jr; CLAIM 2024 Update Panel. Checklist for Artificial Intelligence in Medical Imaging (CLAIM): 2024 Update. Radiol Artif Intell. 2024 Jul;6(4):e240300. doi: 10.1148/ryai.240300.