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(Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC)

NCT03848078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2021-02-25

No results posted yet for this study

Summary

A multi-centre randomized non-inferiority trial investigating the (cost-)effectiveness of Optical Coherence Tomography (OCT) versus regular punch biopsy in the diagnosis and subtyping of Basal Cell Carcinoma (BCC).

Conditions

Interventions

DEVICE

Optical Coherence Tomography

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. In such ways, microscopic details of lesions and tissues can be visualized. This information can be used to identify a lesion as BCC, and to specify the subtype. Therefore, we assume that the use of the OCT might reduce the number of biopsies and the accompanying morbidity. The investigator scans 6mm of skin with the OCT (30 seconds) and decides whether the lesion is a BCC or not.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Klara Mosterd, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2021-08-31
Completion
2021-10-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848078 on ClinicalTrials.gov