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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.
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 BCC/62 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-OCT | Group of 124 patients with equivocal BCC lesions. Of these lesions, OCT scans have been obtained in the past. These scans will be evaluated with AI-assistance. |
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| Unaided OCT | Group of 124 patients with equivocal BCC lesions (same patients as in AI-OCT group). Of these lesions, OCT scans have been obtained in the past. These scans will be evaluated without AI-assistance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography | Diagnostic Test | Optical coherence tomography: OCT is a non-invasive CE-certified diagnostic modality based on light interferometry. An OCT scan visualizes an area with a diameter of 6mm thereby revealing the skin and adnexal structures with a depth of approximately 1.5mm. 3mm punch biopsy: the patients included in this study underwent a 3mm punch biopsy conform regular care. The subsequent histopathological examination of the biopsy specimen serves as ground truth diagnosis of the lesions (gold standard) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of high-confidence diagnoses | The difference in percentage of high-confidence diagnoses will be evaluated between AI-OCT and unaided OCT. | 31-12-2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of high-confidence diagnoses | Diagnostic parameters (sensitivity, specificity, positive predictive value, negative predicted value, diagnostic odds ratio) will be estimated for high-confidence diagnoses made by AI-OCT and unaided OCT. | 31-12-2023 |
| Diagnostic parameters for BCC subtyping |
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Inclusion Criteria:
Exclusion Criteria:
- Patient unable to sign informed consent
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Scans of patients with equivocal BCC lesions will be included. Patients previously underwent an OCT scan and punch biopsy for their lesion. Patients signed informed consent for the use of the OCT scans made and patient information for the sake of answering research questions regarding OCT.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center+ | Recruiting | Maastricht | Limbrug | 6202AZ | Netherlands |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
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Differences in diagnostic parameters for BCC subtyping (sBCC/nBCC/iBCC) will be evaluated (explorative) |
| 31-12-2023 |
| D018295 |
| Neoplasms, Basal Cell |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |