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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Neoplasms, Basal Cell; Implementation; Optical Coherence Tomography (OCT); Carcinoma, Basal Cell (BCC); Real-world Study; Basal Cell Carcinoma of Skin

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 297

Contacts and Locations

• Study Contact: Name: Klara Mosterd, MD PhD; Phone Number: +31(0)43- 387 7295
• Study Contact Backup: Name: Yara Valkenburg, MD; Phone Number: +31(0)43- 387 7295; Email: yara.valkenburg@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • Maastricht University Medical Center +
      • Contact: Klara Mosterd, MD PhD; Phone Number: +31(0)43- 387 7295
      • Contact: Yara Valkenburg, MD; Phone Number: +31(0)43- 387 7295; Email: yara.valkenburg@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with lesions clinically suspected for BCC who visited the Mohs Clinics between January 2025 and June 2025 and underwent LC-OCT imaging as part of the diagnostic work-up.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients wit BCC suspected lesions who underwent LC-OCT imaging; Patients with clinically suspected BCC lesions requiring biopsy who underwent LC-OCT imaging as part of routine clinical care at Mohs Clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor free survival	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.	From enrollment to end of treatment at 6-12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy for BCC detection	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).	From enrollment to end of treatment at 6-12 months.
Treatment strategies	Descriptive evaluation of treatment strategies following LC-OCT-guided diagnosis (ie surgical, topical).	From enrollment to end of treatment at 6-12 months.
Number of performed LC-OCT scans	Descriptive evaluation: number of LC-OCT scans performed	From enrollment to 6-12 months
Lesion characteristics	Descriptive: lesion characteristics (size, location)	At baseline
Proportion of biopsies omitted	Proportion of biopsies omitted	From enrollment to end of treatment at 6-12 months.

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Mohs Klinieken

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Non-melanoma skin cancer; Line-Field Optical Coherence Tomography; Real-world evaluation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma; Neoplasms, Basal Cell; Carcinoma, Basal Cell
• Other Study ID Numbers: METC2025-0250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be shared with other researchers upon reasonable request. Requests will be evaluated on a case by case manner.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No