NCT06279143已完成不适用
The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region
时间窗: March 2024-August 2026
To assess if 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 using the standard probe
次要结局
- Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT(March 2024-August 2026)
- Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery(March 2024-August 2026)
- Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC(March 2024-August 2026)
- Observer agreement in identifying presence/absence of BCC lesions, using D-OCT(March 2024-August 2026)
- Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT(March 2024-August 2026)
- Observer agreement in mapping BCC lesions prior to surgery, using D-OCT(March 2024-August 2026)
- Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC(March 2024-August 2026)
- Observer agreement in classifying BCC lesions into subtypes, using D-OCT(March 2024-August 2026)
- Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT(March 2024-August 2026)
研究者
研究点 (2)
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