Optical-Coherence Tomography for the Non-invasive Diagnosis and Subtyping of Basal Cell Carcinoma

NCT05041777 | Unknown

• 1 other identifier: DERMA_OCT_BCC01
• Study Type: observational
• Target: 963
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: To date, the diagnosis and subtyping of basal cell carcinoma (BCC) is verified with histopathology which requires a biopsy. Because this technique is invasive, new non-invasive strategies have been developed, including Optical Coherence Tomography (OCT). This innovative technique enables microscopically detailed examination of lesions, which is useful for diagnosing and identification of various subtypes of BCC. The diagnostic value of the VIVOSIGHT OCT in daily clinical practice, has not been established to date.

Conditions

Basal Cell Carcinoma; Optical Coherence Tomography; Deep Learning; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of OCT in diagnosis and subtyping of BCC

  The main study parameter is the diagnostic value of OCT in diagnosis BCC defined as accuracy, sensitivity, specificity and negative- and positive diagnostic values. An increase of at least 10 percent in specificity and an equal sensitivity of OCT-based diagnosis is expected, compared with the clinical diagnosis and the golden-standard histopathology.

  February 2017-April 2021

Secondary Outcomes (1)

• Developing a deep learning algorithm for automated detection of basal cell carcinoma (BCC) and recognizing three different BCC subtypes in OCT images.

  June 2020-August 2021

Study Arms (2)

Prospective data collection, retrospective OCT image evaluation

From February 2017-June 2017 patients were included prospectively. OCT images were evaluated retrospectively in conjunction with clinical images. A deep learning algorithm is developed with use of this dataset including 676 OCT images.

Device: Optical Coherence Tomography

Prospective data collection and OCT image evaluation

From January 2021-April 2021 patients were included prospectively. OCT images were evaluated prospectively in a clinical setting. The deep learning algorithm will be prospectively validated with use of this dataset including 287 OCT images.

Device: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DEVICE

OCT is an imaging technique, which is able to produce real-time, in vivo, cross-sectional images of lesions with a depth of 1,5-2 mm. OCT imaging is based on light-interferometry, calculating the interference of an optical beam reflected by the tissue with a reference. \[2\] In such ways, microscopic details of lesions and tissues can be visualized. This information could be used to identify a lesion as BCC, and further specify the subtype. Therefore, the use of the OCT can reduce the number of biopsies and the accompanying morbidity.

Prospective data collection and OCT image evaluation; Prospective data collection, retrospective OCT image evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy

You may qualify if:

• Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy

You may not qualify if:

• Patients who were incompetent to sign informed consent were excluded

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Maastricht University: collaborator

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

• Sinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6.

  PMID: 32147505 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Klara Mosterd, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: February 15, 2017
• Primary Completion: April 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-05

Locations

NL (1)