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NCT Number: NCT07501780

Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice

Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions.

This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.

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Key information

Conditions

Basal Cell Carcinoma of Skin Carcinoma Carcinoma, Basal Cell Carcinoma, Basal Cell (BCC) Implementation Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Optical Coherence Tomography (OCT) Real-world Study

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Basal cell carcinoma (BCC) is the most common type of skin cancer in the Netherlands, with its incidence having increased substantially in recent years. ). Over the past decades, non-invasive imaging techniques such as line-field confocal optical coherence tomography (LC-OCT) have emerged as promising alternatives to biopsy for the diagnosis of BCC. When BCC can be diagnosed with high confidence using (LC-)OCT, this may reduce the need for biopsies, accelerate treatment initiation, and improve healthcare efficiency. LC-OCT combines the principles of conventional optical coherence tomography (OCT) and reflectance confocal microscopy (RCM), enabling three-dimensional visualization of the skin at a cellular resolution.

Several studies have reported a high specificity of LC-OCT for identifying non-BCC lesions, ranging from 97-99%. In cases where BCC can be diagnosed with high confidence, biopsy may theoretically be omitted, meaning that treatment could be initiated promptly. Reported sensitivities for such "high-confidence" BCC diagnoses range from 95-100%.

Although the diagnostic accuracy of LC-OCT has been investigated extensively in research settings, evidence on its real-world clinical performance remains limited. This retrospective study aims to evaluate the clinical utility of LC-OCT in routine dermatological practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years
  • LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands
  • Histopathological results (biopsy or excision) and/or 6-12 month clinical follow-up data available

Exclusion criteria

  • Patients <18 years of age
  • Cases without histopathological confirmation or available follow-up data

Treatment and study plan

Primary outcomes

  1. Tumor free survival

    Time frame: From enrollment to end of treatment at 6-12 months.

    Tumor-free survival rate at 6-12 months follow-up among patients with lesion(s) clinically suspicious for BCC, who were treated based on an LC-OCT-guided diagnosis, with treatment success defined as the absence of residual or recurrent tumor.

Secondary outcomes

  1. Diagnostic accuracy for BCC detection

    Time frame: From enrollment to end of treatment at 6-12 months.

    Diagnostic parameters (sensitivity, specificity, positive predictive value, negative predictive value, diagnostic odds ratio) will be estimated for diagnosis made by LC-OCT (with histopathology serving as reference standard).

  2. Treatment strategies

    Time frame: From enrollment to end of treatment at 6-12 months.

    Descriptive evaluation of treatment strategies following LC-OCT-guided diagnosis (ie surgical, topical).

  3. Number of performed LC-OCT scans

    Time frame: From enrollment to 6-12 months

    Descriptive evaluation: number of LC-OCT scans performed

  4. Lesion characteristics

    Time frame: At baseline

    Descriptive: lesion characteristics (size, location)

  5. Proportion of biopsies omitted

    Time frame: From enrollment to end of treatment at 6-12 months.

    Proportion of biopsies omitted

Study contacts

Contact information is provided by the study sponsor or research team.

Klara Mosterd, MD PhD

CONTACT

+31(0)43- 387 7295

Yara Valkenburg, MD

CONTACT

[email protected]

+31(0)43- 387 7295

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Mohs Klinieken

Registry information

Official study title

Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study

Acronym: RELI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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