Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817279
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-04-04
Brief Title:
AI-aided Optical Coherence Tomography for the Detection of Basal Cell Carcinoma
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
AI-aided Optical Coherence Tomography for the Detection of Basal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Basal cell carcinoma BCC is the most common form of cancer among the Caucasian population A BCC diagnosis is commonly establish by means of an invasive punch biopsy golden standard Optical coherence tomography OCT is a safe non-invasive diagnostic modality which may replace biopsy if an OCT assessor is able to establish a high confidence BCC diagnosis Hence for clinical implementation of OCT diagnostic certainty should be as high as possible Artificial intelligence in the form of a clinical decision support system CDSS may improve the diagnostic certainty of newly trained OCT assessors by highlighting suspicious areas on OCT scans and by providing diagnostic suggestions classification This study will evaluate the effect of a CDSS on the diagnostic certainty and accuracy of OCT assessors
Detailed Description:
In this diagnostic case control design OCT assessors will retrospectively evaluate OCT scans of equivocal BCC lesions twice once with and once without the help of the CDSS A total of 124 scans 62 BCC62 non-BCC will be included in the study Cases will be shuffled to prevent recall bias AI-aided OCT scans and unaided OCT scans will be presented in alternating order The assessors will express their certainty level on a 5-point confidence scale The diagnostic certainty and diagnostic accuracy of OCT assessment with CDSS and without CDSS will be compared
Research questions
1 Does AI-aided OCT assessment result in an increase in high-confidence diagnoses compared to unaided OCT assessment
2 Does AI-aided OCT assessment result in a significant increase in sensitivity for BCC detection without compromising specificity compared to unaided OCT assessment
3 Does AI-aided OCT assessment result in more accurate BCC subtyping compared to unaided OCT assessment explorative
Research questions
1 Does AI-aided OCT assessment result in an increase in high-confidence diagnoses compared to unaided OCT assessment
2 Does AI-aided OCT assessment result in a significant increase in sensitivity for BCC detection without compromising specificity compared to unaided OCT assessment
3 Does AI-aided OCT assessment result in more accurate BCC subtyping compared to unaided OCT assessment explorative
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None