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Added Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment

Optical Coherence Tomography for Diagnosing Recurrent Basal Cell Carcinoma After Non-invasive Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05581342
Acronym
TOBI
Enrollment
100
Registered
2022-10-14
Start date
2021-01-15
Completion date
2022-03-04
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Keywords

Optical coherence tomography

Brief summary

Superficial basal cell carcinoma (sBCC) can be treated non-invasively, but follow-up is necessary because lesions can reoccur. This study aims to evaluate the additional value of optical coherence tomography (OCT) for the detection of recurrent BCC lesions, that may remain unrecognized by clinical and dermoscopic examination (CDE). This study compared the diagnostic accuracy of CDE and CDE combined with OCT for detection of recurrent basal cell carcinoma (BCC) after non-invasive treatment of sBCC.

Interventions

DIAGNOSTIC_TESTPunch biopsy (3mm)

In case of suspicion of recurrence or a voluntary control biopsy; a punch biopsy (3mm) was obtained conform regular care.

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Masking description

The OCT assessor was blinded to the histopathological examination of the independent dermatopathologist, whereas the dermatopathologist was blinded to the OCT assessment.

Intervention model description

Patients who were non-invasively treated for superficial basal cell carcinoma within five years post-treatment could be included. If CDE or OCT rose suspicion for recurrence a biopsy was obtained. When no suspicion for recurrence was raised; patients were asked to voluntarily undergo a control biopsy to verify absence of recurrence.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Non-invasively treated sBCC patients * 18+ years of age

Exclusion criteria

* Unable to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
The added value of OCT for the detection of recurrent BCC1- 56 months post treatmentThe investigators evaluated the difference in sensitivity between CDE and CDE + OCT

Secondary

MeasureTime frameDescription
The number of false-positive OCT test results1- 56 months post treatmentThe investigators evaluated whether the addition of OCT to CDE led to false-positive test results. (i.e a decrease in specificity)
Subtyping recurrent BCC by OCT1- 56 months post treatmentThe investigators evaluated to what extent OCT assessors are able to correctly predict the BCC subtype of recurrent BCCs. A distinction was made between superficial BCC (sBCC; non-invasive treatment optional) and nodular/aggressive BCC (nBCC/aBCC; excision required). For BCC subtyping, sensitivity was defined as the proportion of patients with an nBCC/aBCC correctly identified by OCT as nBCC/aBCC. Specificity was defined as the proportion of patients with an sBCC correctly identified as sBCC by OCT.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026