Basal Cell CarcinomaOCT-BCCNCT05041777
Optical-Coherence Tomography for the Non-invasive Diagnosis and Subtyping of Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma and Optical Coherence Tomography, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: To date, the diagnosis and subtyping of basal cell carcinoma (BCC) is verified with histopathology which requires a biopsy. Because this technique is invasive, new non-invasive strategies have been developed, including Optical Coherence Tomography (OCT). 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, Deep Learning
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 963 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Feb 2017to 30 Dec 2021
- 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
- Adult, Older adult
Study population: Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy
Who may be able to join
- Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy
Who cannot join
- Patients who were incompetent to sign informed consent were excluded
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6229HX
About this study
Rationale:
To date, the diagnosis and subtyping of basal cell carcinoma (BCC) is verified with histopathology which requires a biopsy. Because this technique is invasive, new non-invasive strategies have been developed, including Optical Coherence Tomography (OCT). This innovative technique enables microscopically detailed examination of lesions, which is useful for diagnosing and identification of various subtypes of BCC. The diagnostic value of the VIVOSIGHT OCT in daily clinical practice, has not been established to date.
Read the detailed description
Objective:
The aim of the study is to investigate the diagnostic value and usability of OCT in the diagnosis and subtyping of clinically suspect BCC.
Study design:
In this prospective observational trial, the VIVOSIGHT OCT device will be used on all patients attending the policlinic Dermatology of the MUMC and will undergo a skin biopsy. Information collected from OCT images will be compared with the clinical diagnosis by the specialist, including dermatoscopy, and the gold standard consisting of the histopathological diagnosis obtained from biopsy.
Study population:
All patients attending the policlinic Dermatology of the MUMC that will undergo a skin biopsy.
Intervention:
In this study, patients will be asked for informed consent to participate in this study before the planned biopsy is performed. The consent includes the undergoing of the imaging and extracting the pathology report from the patient's file. Imaging of the lesion will be performed subsequently, which is non-invasive and requires only several minutes of time. After the imaging, the patient is treated conform regular care: the following biopsy will be send for histopathologic examination by the pathologist, and the patient will hear the outcome of this investigation via his or her own physician. The histopathologic diagnosis and subtype will be obtained from the pathology report to compare with the diagnosis and subtype based on clinical diagnosis and OCT imaging.
Main study parameters/endpoints:
The main study parameters comprise the diagnostic value of OCT imaging for BCC, defined as the sensitivity, specificity, positive- and negative predictive value, compared with the clinical diagnosis and the gold standard of histopathological diagnosis. Secondary outcome is the value of OCT for subtyping BCC. Retrospectively, the necessity of a biopsy to confirm the diagnosis will be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This research is conducted during regular patient care. Patients that are planned to have a skin biopsy for histopathological study will be asked to participate and provide informed consent. When a biopsy is planned, the OCT imaging will be performed while the patients are waiting for the biopsy to be prepared, the OCT imaging process is performed by the investigator. The outcome of the planned biopsy will be used as the gold standard for comparison with OCT. The results of this biopsy will be extracted from the pathology report in the electronic patient history file. Possible risks for biopsies are not influenced by the OCT imaging apparatus and include: post-operative bleeding, allergic reactions, wound infection and hematoma formation. With OCT imaging valuable information can be obtained without influencing the regular care procedure. This is benificial because in the future the non-invasive OCT might replace invasive skin biopsies.
- Conditions
- Basal Cell Carcinoma, Optical Coherence Tomography, Deep Learning, Artificial Intelligence
- Being tested
- Optical Coherence Tomography
- 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.
Optical Coherence TomographyDevice
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. [2] In such ways, microscopic details of lesions and tissues can be visualized. This information could be used to identify a lesion as BCC, and further specify the subtype. Therefore, the use of the OCT can reduce the number of biopsies and the accompanying morbidity.
| Study group | Role | What they receive |
|---|---|---|
| Prospective data collection, retrospective OCT image evaluation | From February 2017-June 2017 patients were included prospectively. OCT images were evaluated retrospectively in conjunction with clinical images. A deep learning algorithm is developed with use of this dataset including 676 OCT images. Receives: Device: Optical Coherence Tomography | |
| Prospective data collection and OCT image evaluation | From January 2021-April 2021 patients were included prospectively. OCT images were evaluated prospectively in a clinical setting. The deep learning algorithm will be prospectively validated with use of this dataset including 287 OCT images. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of OCT in diagnosis and subtyping of BCC
The main study parameter is the diagnostic value of OCT in diagnosis BCC defined as accuracy, sensitivity, specificity and negative- and positive diagnostic values. An increase of at least 10 percent in specificity and an equal sensitivity of OCT-based diagnosis is expected, compared with the clinical diagnosis and the golden-standard histopathology.
Measured: February 2017-April 2021
Secondary outcomes (1)
Developing a deep learning algorithm for automated detection of basal cell carcinoma (BCC) and recognizing three different BCC subtypes in OCT images.
The ability of a deep learning algorithm to classify BCC from other skin lesions within OCT images
Measured: June 2020-August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start15 Feb 2017
- Primary completion30 Apr 2021
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Klara Mosterd, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041777
- Sponsor's protocol ID
- DERMA_OCT_BCC01
- Acronym
- OCT-BCC
- Status last verified
- May 2021
- First submitted
- 3 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6.
PubMed 32147505
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical-Coherence Tomography for the Non-invasive Diagnosis and Subtyping of Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05041777
- Acronym / sponsor ID
- OCT-BCC / DERMA_OCT_BCC01
- Conditions
- Basal Cell Carcinoma, Optical Coherence Tomography, Deep Learning, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Sep 2021 (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.
Rationale:
To date, the diagnosis and subtyping of basal cell carcinoma (BCC) is verified with histopathology which requires a biopsy. Because this technique is invasive, new non-invasive strategies have been developed, including Optical Coherence Tomography (OCT). This innovative technique enables microscopically detailed examination of lesions, which is useful for diagnosing and identification of various subtypes of BCC. The diagnostic value of the VIVOSIGHT OCT in daily clinical practice, has not been established to date.
Detailed description
Objective:
The aim of the study is to investigate the diagnostic value and usability of OCT in the diagnosis and subtyping of clinically suspect BCC.
Study design:
In this prospective observational trial, the VIVOSIGHT OCT device will be used on all patients attending the policlinic Dermatology of the MUMC and will undergo a skin biopsy. Information collected from OCT images will be compared with the clinical diagnosis by the specialist, including dermatoscopy, and the gold standard consisting of the histopathological diagnosis obtained from biopsy.
Study population:
All patients attending the policlinic Dermatology of the MUMC that will undergo a skin biopsy.
Intervention:
In this study, patients will be asked for informed consent to participate in this study before the planned biopsy is performed. The consent includes the undergoing of the imaging and extracting the pathology report from the patient's file. Imaging of the lesion will be performed subsequently, which is non-invasive and requires only several minutes of time. After the imaging, the patient is treated conform regular care: the following biopsy will be send for histopathologic examination by the pathologist, and the patient will hear the outcome of this investigation via his or her own physician. The histopathologic diagnosis and subtype will be obtained from the pathology report to compare with the diagnosis and subtype based on clinical diagnosis and OCT imaging.
Main study parameters/endpoints:
The main study parameters comprise the diagnostic value of OCT imaging for BCC, defined as the sensitivity, specificity, positive- and negative predictive value, compared with the clinical diagnosis and the gold standard of histopathological diagnosis. Secondary outcome is the value of OCT for subtyping BCC. Retrospectively, the necessity of a biopsy to confirm the diagnosis will be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This research is conducted during regular patient care. Patients that are planned to have a skin biopsy for histopathological study will be asked to participate and provide informed consent. When a biopsy is planned, the OCT imaging will be performed while the patients are waiting for the biopsy to be prepared, the OCT imaging process is performed by the investigator. The outcome of the planned biopsy will be used as the gold standard for comparison with OCT. The results of this biopsy will be extracted from the pathology report in the electronic patient history file. Possible risks for biopsies are not influenced by the OCT imaging apparatus and include: post-operative bleeding, allergic reactions, wound infection and hematoma formation. With OCT imaging valuable information can be obtained without influencing the regular care procedure. This is benificial because in the future the non-invasive OCT might replace invasive skin biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective data collection, retrospective OCT image evaluation | – | Device: Optical Coherence TomographyFrom February 2017-June 2017 patients were included prospectively. OCT images were evaluated retrospectively in conjunction with clinical images. A deep learning algorithm is developed with use of this dataset including 676 OCT images. |
| Prospective data collection and OCT image evaluation | – | Device: Optical Coherence TomographyFrom January 2021-April 2021 patients were included prospectively. OCT images were evaluated prospectively in a clinical setting. The deep learning algorithm will be prospectively validated with use of this dataset including 287 OCT images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy
Key inclusion criteria (1 listed)
- Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy
Key exclusion criteria (1 listed)
- Patients who were incompetent to sign informed consent were excluded
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 |
|---|---|---|
| Optical Coherence TomographyOCT 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. [2] In such ways, microscopic details of lesions and tissues can be visualized. This information could be used to identify a lesion as BCC, and further specify the subtype. Therefore, the use of the OCT can reduce the number of biopsies and the accompanying morbidity. | Device | Prospective data collection and OCT image evaluation, Prospective data collection, retrospective OCT image evaluation |
Primary outcome
Diagnostic accuracy of OCT in diagnosis and subtyping of BCC
Time frame: February 2017-April 2021
The main study parameter is the diagnostic value of OCT in diagnosis BCC defined as accuracy, sensitivity, specificity and negative- and positive diagnostic values. An increase of at least 10 percent in specificity and an equal sensitivity of OCT-based diagnosis is expected, compared with the clinical diagnosis and the golden-standard histopathology.
1 secondary outcome
Developing a deep learning algorithm for automated detection of basal cell carcinoma (BCC) and recognizing three different BCC subtypes in OCT images.
Time frame: June 2020-August 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Results publication: PubMed 32147505Sinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Maastricht University Medical Center
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 Basal Cell Carcinoma and Optical Coherence Tomography, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 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 13 Sep 2021. 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 Netherlands. 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?
Results are not available in the source record.
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 OCT in diagnosis and subtyping of BCC (time frame: February 2017-April 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041777, which also lists 1 linked publication.
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 13 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.