The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes

Trial Title: The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes

NCT ID: NCT06279143

Condition: BCC - Basal Cell Carcinoma
BCC
Skin Diseases
Eyelid Tumor
Eyelid Diseases

Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Eyelid Diseases
Skin Diseases

Conditions: 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

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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

Criteria for eligibility:

Study pop:
Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital

Address:
City: Vejle
Zip: 7100
Country: Denmark

Status: Recruiting

Contact:
Last name: Sveina B Karlsdóttir, MD

Phone: 53420448

Phone ext: 0045
Email: sveina@outlook.dk

Contact backup:
Last name: Susanne Støvring

Phone: 79406461

Phone ext: 0045
Email: susanne.stoevring@rsyd.dk

Start date: April 4, 2024

Completion date: November 30, 2026

Lead sponsor:
Agency: Vejle Hospital
Agency class: Other

Source: Vejle Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06279143