BCC - Basal Cell CarcinomadOCT-pBCCNCT06279143
The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes
An observational study of BCC - Basal Cell Carcinoma and BCC, run by Vejle Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BCC - Basal Cell Carcinoma, BCC, Skin Diseases
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Apr 2024to 22 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area
Who may be able to join
- Clinically suspected periocular BCC.
- Biopsy-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 informed consent and can comply with protocol requirements.
Who cannot join
- 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 biopsy or excision of lesion.
- Inability to sign informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital
Vejle, Region of Southern Danmark, 7100
About this study
Official title: The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area
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
- Conditions
- 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
- Medical subject headings
- Carcinoma, Basal Cell, Skin Diseases, Eyelid Neoplasms, Eyelid Diseases, Carcinoma, Neoplasms, Glandular and Epithelial, Skin Neoplasms, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: March 2024-August 2026
Secondary outcomes (9)
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.
Measured: March 2024-August 2026
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.
Measured: March 2024-August 2026
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.
Measured: March 2024-August 2026
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.
Measured: March 2024-August 2026
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.
Measured: March 2024-August 2026
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.
Measured: March 2024-August 2026
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.
Measured: March 2024-August 2026
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.
Measured: March 2024-August 2026
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)
Measured: March 2024-August 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start4 Apr 2024
- Primary completion11 Mar 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCC - Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flemming Møller, Assoc.prof., Study director, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279143
- Sponsor's protocol ID
- dOCT-pBCC
- Acronym
- dOCT-pBCC
- Status last verified
- May 2026
- First submitted
- 1 Feb 2024
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Dermal Optical Coherence Tomography (D-OCT) for Clinically Suspected Basal Cell Carcinoma Lesion (BCC) in the Periocular Area
- ClinicalTrials.gov ID
- NCT06279143
- Acronym / sponsor ID
- dOCT-pBCC / dOCT-pBCC
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive enrolment of newly referred patients under the diagnosis "clinically suspected BCC" in the periocular area
Key inclusion criteria (7 listed)
- Clinically suspected periocular BCC.
- Biopsy-verified BCC
- Clinically suspected relapse of periocular BCC
- Age more than 18 years at baseline.
- Legally competent, able to give verbal and written consent
Key exclusion criteria (3 listed)
- 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 biopsy or excision of lesion.
- Inability to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region
Time frame: March 2024-August 2026
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
9 secondary outcomes
Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC
Time frame: March 2024-August 2026
Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC
Time frame: March 2024-August 2026
Observer agreement in identifying presence/absence of BCC lesions, using D-OCT
Time frame: March 2024-August 2026
Observer agreement in classifying BCC lesions into subtypes, using D-OCT
Time frame: March 2024-August 2026
Observer agreement in mapping BCC lesions prior to surgery, using D-OCT
Time frame: March 2024-August 2026
Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT
Time frame: March 2024-August 2026
Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT
Time frame: March 2024-August 2026
Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT
Time frame: March 2024-August 2026
Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery
Time frame: March 2024-August 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Møller, Assoc.prof. study director
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BCC - Basal Cell Carcinoma and BCC, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region (time frame: March 2024-August 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.