Clinical trial NCT06279143: The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes
Official title: The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BCC - Basal Cell Carcinoma
BCC
Skin Diseases
Eyelid Tumor
Eyelid Diseases
Keywords: Carcinoma, Basal Cell* / diagnostic imaging
Carcinoma, Basal Cell* / pathology
Carcinoma, Basal Cell* / surgery
Neoplasm, Glandular and epithelial
Skin neoplasm
Diagnostic imaging
Sensitivity and Specificity
Tomography, Optical Coherence* / methods
Skin Neoplasm* / surgery
Neoplasm recurrence
Eyelids / pathology
Skin diseases
Periocular
BCC
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area

Brief summary: The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area.

The Hypotheses:

* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used.
* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used.
* The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used.
* D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC.
* The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure.
* The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure.
* Delineation of periocular BCC tumour extension is possible using both D-OCT probes


Eligibility criteria: Inclusion Criteria:

* Clinically suspected periocular BCC.
* Biopsy-verified BCC
* Clinically suspected relapse of periocular BCC
* Age more than 18 years at baseline.
* Legally competent, able to give verbal and written consent
* Communicate in Danish verbally as well as in writing
* Willingness to participate and able to give informed consent and can comply with protocol requirements.

Exclusion Criteria:

* Anatomical circumstances that make OCT-scanning impossible, i.e., extensive scarring of eyelids, or large ulcerating crusts that hampers scanning
* Unwillingness to undergo a skin biopsy or excision of lesion.
* Inability to sign informed consent.

Primary outcomes:
measure: Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region
timeFrame: March 2024-August 2026
Secondary outcomes:
measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC
timeFrame: March 2024-August 2026
measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC
timeFrame: March 2024-August 2026
measure: Observer agreement in identifying presence/absence of BCC lesions, using D-OCT
timeFrame: March 2024-August 2026
measure: Observer agreement in classifying BCC lesions into subtypes, using D-OCT
timeFrame: March 2024-August 2026
measure: Observer agreement in mapping BCC lesions prior to surgery, using D-OCT
timeFrame: March 2024-August 2026
measure: Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT
timeFrame: March 2024-August 2026
measure: Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT
timeFrame: March 2024-August 2026
measure: Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT
timeFrame: March 2024-August 2026
measure: Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery
timeFrame: March 2024-August 2026
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital
state: Region Of Southern Danmark
Study officials:
affiliation: Vejle Hospital
name: Flemming Møller, Assoc.prof.
role: STUDY_DIRECTOR
References: