Artificial IntelligenceCLAIMNCT05984082
Checklist for AI in Medical Imaging (CLAIM) Consensus Panel
An observational study of Artificial Intelligence and Machine Learning, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Artificial Intelligence, Machine Learning, Diagnostic Imaging
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 May 2024
- 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 to 89 years
- All sexes
- Adult, Older adult
Study population: Physicians, AI researchers and journal editors
Who may be able to join
- 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
Who cannot join
- Non physicians, AI researchers and journal editors
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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
- Keywords
- Checklist for AI in Medical Imaging (CLAIM), Reporting guideline, Delphi consensus method, Survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Revise the Checklist for AI in Medicine Imaging (CLAIM) guideline
potential revision of the CLAIM guidelines through Delphi consensus process.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Artificial IntelligenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles E. Kahn, Jr., MD, MS, University of Pennsylvania
- Investigators
- Charles E. Kahn, Jr., MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984082
- Sponsor's protocol ID
- 853845
- Acronym
- CLAIM
- Status last verified
- Sep 2024
- First submitted
- 1 Aug 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38809149
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checklist for AI in Medical Imaging (CLAIM) Consensus Panel
- ClinicalTrials.gov ID
- NCT05984082
- Acronym / sponsor ID
- CLAIM / 853845
- Keywords
- Checklist for AI in Medical Imaging (CLAIM), Reporting guideline, Delphi consensus method, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 9 Aug 2023 (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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Physicians, AI researchers and journal editors
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Non physicians, AI researchers and journal editors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Revise the Checklist for AI in Medicine Imaging (CLAIM) guideline
Time frame: 6 months
potential revision of the CLAIM guidelines through Delphi consensus process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Results publication: PubMed 38809149Tejani 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.
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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.
Charles E. Kahn, Jr., MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artificial Intelligence and Machine Learning, run by University of Pennsylvania at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revise the Checklist for AI in Medicine Imaging (CLAIM) guideline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05984082, which also lists 1 linked publication.
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 23 Sep 2024.