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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2021-10-31

Brief Summary

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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).

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Detailed Description

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Skin cancer incidence rises worldwide due to high sun exposure and ageing. Basal cell carcinoma (BCC) is the most prevalent form, with a lifetime risk of 16-20% in the Netherlands. Currently, the gold standard for diagnosing and subtyping BCC is a punch biopsy. Since this technique is invasive, new non-invasive diagnostic methods have been developed, including optical coherence tomography (OCT). In patients with clinical and dermoscopic suspicion of BCC, OCT makes it possible to confirm and subtype BCC with high confidence, thereby obviating the need for a punch biopsy in a substantial part of patients. Hence, BCC diagnosis and treatment can be accomplished in one day. As a result, patients experience less distress and costs can be saved. By discussing diagnosis and treatment with the patient directly, care can be provided more efficiently, preventing treatment delay and saving extra hospital visits. The investigators hypothesize that the use of OCT is a cost-effective strategy when compared to regular care (always punch biopsy). However, it is important to evaluate whether an alternative OCT guided diagnostic approach does not lead to an unacceptable increase in risk of recurrent BCC.

Conditions

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Basal Cell Carcinoma Optical Coherence Tomography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-centre randomised controlled non-inferiority trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

The investigator is blinded for the result of the punch biopsy.

Study Groups

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Optical Coherence Tomography arm

In the intervention arm, OCT imaging is performed which will take about 3 minutes. The decision on the most adequate treatment strategy will be based directly on the OCT diagnosis, but only when there is certainty about the presence of BCC and BCC subtype according to the OCT diagnosis. A 'safety' biopsy will be performed after the OCT scan. In patients where the OCT diagnosis leaves doubt or it is certain that there is no BCC, a biopsy will be taken anyway and the treatment decision will be based on the result of this punch biopsy.

Group Type OTHER

Optical Coherence Tomography

Intervention Type 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. 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.

Regular care arm

In patients assigned to regular care, the result of punch biopsy will always be used to decide which treatment is most adequate. Therefore, a next consultation will be planned to discuss the outcome of the biopsy and the intended treatment strategy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Vivosight, Michelson diagnostics

Eligibility Criteria

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Inclusion Criteria

* Adult patient (\>18 years)
* Clinical and dermoscopic suspicion of BCC
* BCC is in the differential diagnosis and a biopsy would normally be obtained to confirm the diagnosis and subtype or exclude other skin lesions.

Exclusion Criteria

* Patients with BCC in the high-risk zone of the face (ear, nose, eye region)
* Patients with a large BCC referred to our (tertiary care) head and neck tumour working group.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No