ClinicalTrials.gg
CompletedNCT06279143dOCT-pBCCUpdated May 26, 2026

The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes

An observational study in BCC - Basal Cell Carcinoma, BCC and Skin Diseases, sponsored by Vejle Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Vejle Hospital · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
210
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 21 studies in Carcinoma, Basal Cell with a site in Denmark — 2 open to participants now, 4 under way, none of them phase 3. Carcinoma, Basal Cell · Denmark.

Started
2024
the only one that year
Observational
4 of 21
2 open now
Registered
18th of 21
by date

Among the 21 studies in Carcinoma, Basal Cell with a site in Denmark, this one is the only one that started in 2024, is one of 4 observational ones, and was the 18th registered.

Carcinoma, Basal Cell

389 studies on the registry are indexed under Carcinoma, Basal Cell; 69 are open to participants now.

Browse Carcinoma, Basal Cell studies →

Open to participants now

2 of the 21 studies in Carcinoma, Basal Cell with a site in Denmark are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 52 Carcinoma, Basal Cell studies recruiting now, 48 (92%) set no upper age limit and none (0%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area.

The Hypotheses:

  • The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used.
  • The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used.
  • The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used.
  • D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC.
  • The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure.
  • The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure.
  • Delineation of periocular BCC tumour extension is possible using both D-OCT probes
03

Conditions studied

  • BCC - Basal Cell Carcinoma
  • BCC
  • Skin Diseases
  • Eyelid Tumor
  • Eyelid Diseases

Keywords

  • Carcinoma, Basal Cell* / diagnostic imaging
  • Carcinoma, Basal Cell* / pathology
  • Carcinoma, Basal Cell* / surgery
  • Neoplasm, Glandular and epithelial
  • Skin neoplasm
  • Diagnostic imaging
  • Sensitivity and Specificity
  • Tomography, Optical Coherence* / methods
  • Skin Neoplasm* / surgery
  • Neoplasm recurrence
  • Eyelids / pathology
  • Skin diseases
  • Periocular
  • BCC
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinically suspected periocular BCC.
  • -verified BCC
  • Clinically suspected relapse of periocular BCC
  • Age more than 18 years at baseline.
  • Legally competent, able to give verbal and written consent
  • Communicate in Danish verbally as well as in writing
  • Willingness to participate and able to give and can comply with protocol requirements.

Exclusion criteria

Exclusion Criteria:

  • Anatomical circumstances that make OCT-scanning impossible, i.e., extensive scarring of eyelids, or large ulcerating crusts that hampers scanning
  • Unwillingness to undergo a skin or excision of lesion.
  • Inability to sign .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
210 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region

    To assess if the sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region using the standard probe

    Time frame: March 2024-August 2026

Secondary outcomes

  1. Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC

    To compare the sensitivity and specificity of each D-OCT probe for diagnosing periocular BCC, with reference to punch biopsy results.

    Time frame: March 2024-August 2026

  2. Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC

    To compare the sensitivity and specificity of each D-OCT probe for subtyping periocular BCC, with reference to punch biopsy results.

    Time frame: March 2024-August 2026

  3. Observer agreement in identifying presence/absence of BCC lesions, using D-OCT

    This measure, assesses the consistency among observers in identifying the presence or absence of BCC lesions through the utilization of D-OCT imaging.

    Time frame: March 2024-August 2026

  4. Observer agreement in classifying BCC lesions into subtypes, using D-OCT

    This measure, evaluates the level of agreement among observers in categorizing BCC lesions into specific subtypes based on D-OCT imaging. Potential diagnostic features from lesion types will be tested.

    Time frame: March 2024-August 2026

  5. Observer agreement in mapping BCC lesions prior to surgery, using D-OCT

    This measure, examines the agreement among observers in accurately mapping the extension of BCC lesions prior to surgery with the assistance of D-OCT imaging.

    Time frame: March 2024-August 2026

  6. Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT

    This measure, quantifies the improvement in skills over time among observers in diagnosing BCC lesions using D-OCT imaging. It aims to determine the rate at which observers become adept at interpreting D-OCT images for BCC diagnosis.

    Time frame: March 2024-August 2026

  7. Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT

    This measure, quantifies the improvement in skills over time among observers in accurately identifying different subtypes of BCC lesions using D-OCT imaging. It aims to determine the rate at which observers become adept at interpreting D-OCT images for BCC subtyping.

    Time frame: March 2024-August 2026

  8. Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT

    This measure, quantifies the improvement in skills over time among observers in precisely delineating the borders of BCC lesions prior to surgery using D-OCT imaging. It assesses the improvement in demarcation accuracy with increasing experience.

    Time frame: March 2024-August 2026

  9. Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery

    Evaluation af sensitivity of D-OCT imaging in delineation (mapping) of periocular BCC tumour extension - comparing findings with visible boundaries and histopathological diagnosis (considered the gold standard)

    Time frame: March 2024-August 2026

07

Study locations

1 site
  • Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital
    Vejle, Region of Southern Danmark 7100, Denmark
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2024 to primary completion in Mar 2026, 23 months.

Of 40 observational studies under Carcinoma, Basal Cell, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 75. This study's 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2024
First posted
Feb 26, 2024
StartActual
Apr 4, 2024
Primary completionActual
Mar 11, 2026
CompletionActual
May 22, 2026
Last update
May 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06279143
Lead sponsor
Vejle Hospital
Responsible party
Sponsor
First posted
Feb 26, 2024
Start date
Apr 4, 2024
Primary completion
Mar 11, 2026
Completion
May 22, 2026
Last update
May 26, 2026

Study contacts

Flemming Møller, Assoc.prof.
study director · Vejle Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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