Basal Cell CarcinomaNCT06273722
D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study
An observational study of Basal Cell Carcinoma and Optical Coherence Tomography, run by Maastricht University Medical Center.
Trial summary
The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Optical Coherence Tomography
- What is being tested?
- Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
- Type of treatment
- Medical device
- How many people
- 424 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Aug 2025
- 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: This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment.
Who may be able to join
- 18+ years
- Lesions suspect for non-melanoma skin cancer or premalignancy
- Patient underwent D-OCT scan and biopsy conform regular care
Who cannot join
- Patient unable to sign informed consent.
Trial locations and contacts
No sites are listed yet.
Klara Mosterd, MD PhD contact
About this study
Official title: Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell
The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.
Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.
- Conditions
- Basal Cell Carcinoma, Optical Coherence Tomography
- Being tested
- Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
- Keywords
- Basal cell carcinoma, Optical coherence tomography, Imaging, Non-melanoma skin cancer
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivosight Multi-beam Swept-Source Frequency Domain OCT scannerDevice
Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm).
| Study group | Role | What they receive |
|---|---|---|
| D-OCT scanned patients | This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment. Receives: Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy for BCC detection on D-OCT assessment
We will evaluate the ability of OCT assessors to discriminate BCC from non-BCC using OCT without and with dynamic functionality. The diagnostic certainty for BCC detection will be expressed on a five-point confidence scale. A high confidence score (confidence score=4) is considered a positive OCT test results. In these cases, biopsy could effectively be omitted. Lower confidence scores (confidence score≤3) are considered negative OCT test results as in these cases, biopsy remains necessary for a definitive or alternative diagnosis. The primary outcome of interest is the sensitivity of a high confidence BCC diagnosis because we want to evaluate whether the dynamic functionality increases the proportion of correctly classified BCCs.
Measured: Measured before December 31st 2024
Secondary outcomes (2)
Diagnostic accuracy for BCC subtyping on D-OCT assessment
We will evaluate the ability of OCT assessors to discriminate each individual BCC subtype from the other two subtypes using OCT without and with dynamic functionality. Cases that resulted in a high confidence diagnosis (confidence score=4) will be included in the analyses. Three analyses will be performed to calculate the sensitivity to detect sBCC, nBCC or iBCC and the specificity to identify non-sBCC, non-nBCC or non-iBCC subtypes using histopathology as reference test. In this respect, sensitivity is defined as the proportion of a specific BCC subtype, that is correctly classified as such by the OCT assessor (i.e. sBCC, nBCC or iBCC), whereas specificity is defined as the proportion of the other two subtypes that is correctly classified as such (i.e sBCC/nBCC, sBCC/iBCC or nBCC/iBCC). The primary outcome of interest is the sensitivity. We want to evaluate whether the dynamic functionality increases the proportion of correctly classified subtypes .
Measured: Measured before December 31st 2024
Diagnostic value of vascular structures and patterns
Diagnostic odds ratios (DORs ) are used to identify subsets of vascular features and patterns that can be used to accurately discriminate BCC subtypes. The histopathological subtype (i.e. sBCC, nBCC, iBCC ) vs. other subtypes (i.e sBCC/nBCC, sBCC/iBCC, nBCC/iBCC) will be used as the dependent variable. A DOR >1 indicates that the presence of a vascular feature or pattern is indicative for the presence of the respective BCC subtype.
Measured: Measured before December 31st 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273722
- Sponsor's protocol ID
- 2024-0059
- Status last verified
- Oct 2024
- First submitted
- 15 Feb 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared with other researchers upon reasonable request. Requests will be evaluated on a case by case manner.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell
- ClinicalTrials.gov ID
- NCT06273722
- Acronym / sponsor ID
- 2024-0059
- Conditions
- Basal Cell Carcinoma, Optical Coherence Tomography
- Keywords
- Basal cell carcinoma, Optical coherence tomography, Imaging, Non-melanoma skin cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 22 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 current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.
Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-OCT scanned patients | – | Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scannerThis diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment.
Key inclusion criteria (3 listed)
- 18+ years
- Lesions suspect for non-melanoma skin cancer or premalignancy
- Patient underwent D-OCT scan and biopsy conform regular care
Key exclusion criteria (1 listed)
- Patient unable 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivosight Multi-beam Swept-Source Frequency Domain OCT scannerVivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). | Device | D-OCT scanned patients |
Primary outcome
Diagnostic accuracy for BCC detection on D-OCT assessment
Time frame: Measured before December 31st 2024
We will evaluate the ability of OCT assessors to discriminate BCC from non-BCC using OCT without and with dynamic functionality. The diagnostic certainty for BCC detection will be expressed on a five-point confidence scale. A high confidence score (confidence score=4) is considered a positive OCT test results. In these cases, biopsy could effectively be omitted. Lower confidence scores (confidence score≤3) are considered negative OCT test results as in these cases, biopsy remains necessary for a definitive or alternative diagnosis. The primary outcome of interest is the sensitivity of a high confidence BCC diagnosis because we want to evaluate whether the dynamic functionality increases the proportion of correctly classified BCCs.
2 secondary outcomes
Diagnostic accuracy for BCC subtyping on D-OCT assessment
Time frame: Measured before December 31st 2024
Diagnostic value of vascular structures and patterns
Time frame: Measured before December 31st 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Undecided. IPD may be shared with other researchers upon reasonable request. Requests will be evaluated on a case by case manner.
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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.
Klara Mosterd, MD PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma and Optical Coherence Tomography, run by Maastricht University Medical Center.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Wolswijk, MD MSc (+31(0)43- 387 7295, tom.wolswijk@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy for BCC detection on D-OCT assessment (time frame: Measured before December 31st 2024). 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 Oct 2024.