Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024629
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-08-29
Brief Title:
cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma a Diagnostic Cohort Study
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma a Diagnostic Cohort Study
Status:
ACTIVE_NOT_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 Equivocal BCC lesions are usually diagnosed by means of a punch biopsy but since the last few decades non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology Conventional optical coherence tomography cOCT is an example of a non-invasive imaging technique Recent studies revealed that OCT assessors may achieve high diagnostic certainty and accuracy for diagnosing BCC However cOCT has a limited axial and lateral resolution and can therefore only visualize the gross architecture of the skin It has been proposed that the diagnostic certainty and accuracy of cOCT could be optimized by improving the resolution Line-field confocal optical coherence tomography LC-OCT is a new non-invasive imaging technique that provides tridimensional images of the skin with a cellular resolution Although the resolution of LC-OCT is superior to cOCT the penetration depth of LC-OCT 500µm is limited compared to that of cOCT 10-15mm In the proposed study we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic accuracy for diagnosing BCC in equivocal BCC lesions
Detailed Description:
None
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