Basal Cell CarcinomaNCT07482956
BCC-One-Stop-Study
A study testing Margin Mapping with Line-field confocal optical coherence tomography in people with Basal Cell Carcinoma, run by University Hospital Augsburg at 5 sites in Germany.
Trial summary
Basal cell carcinoma (BCC) is the most common malignant skin tumour. The standard treatment is micrographically controlled surgery (MMS), which achieves high cure rates but requires considerable time and personnel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Margin Mapping with Line-field confocal optical coherence tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults (≥18 years) with basal cell carcinoma (BCC) scheduled for Mohs micrographic surgery (MMS),
- Diagnosis confirmed by dermoscopy and histopathology or optical coherence tomography (OCT),
- No limitation regarding tumor size or BCC subgroups.
Who cannot join
- Poor LC-OCT image quality,
- Incomplete adherence to the study protocol,
- Previous treatment of the BCC,
- Anatomical sites that are difficult to access with LC-OCT (e.g., inner ear, medial canthus of the eye).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites
University Hospital Augsburg
Augsburg
Julia Welzel, MD, julia.welzel@uk-augsburg.de
Sandra Schuh, MD, M.Sc., sandra.schuh@uk-augsburg.de
University Hospital Dresden
Dresden
Sarah Hobelsberger, MD, sarah.hobelsberger@ukdd.de
Frank F Gellrich, MD, FrankFriedrich.Gellrich@ukdd.de
University Hospital Erlangen
Erlangen
Carola Berking, MD, carola.berking@uk-erlangen.de
Moritz Ronicke, MD, moritz.ronicke@uk-erlangen.de
Ludwig Maximilian University Hospital
Munich
Elke C Sattler, MD, elke.sattler@med.uni-muenchen.de
Charlotte Gust, MD, charlotte.gust@med.uni-muenchen.de
München Klinik
Munich
Daniela Hartmann, MD, PhD, daniela.hartmann@muenchen-klinik.de
Maximilian Deußing, MD, maximilian.deussing@muenchen-klinik.de
About this study
Official title: Multicentre, Interventional Prospective Study to Evaluate the Efficiency of Pre- and Postoperative Margin Determination of Basal Cell Carcinomas Using Optical Coherence Tomography and Line-field Confocal Optical Coherence Tomography During Micrographically Controlled Surgery
Basal cell carcinoma (BCC) is the most common malignant skin tumour. The standard treatment is micrographically controlled surgery (MMS), which achieves high cure rates but requires considerable time and personnel. A key problem is the inadequate preoperative determination of tumour margins, which often leads to multiple cycles of excision.
The aim of this multicentre, prospective, randomised controlled intervention study is to evaluate line-field confocal optical coherence tomography (LC-OCT) for preoperative margin determination in BCC within the framework of MMS.
Read more
Research question:
Can preoperative LC-OCT-assisted margin marking increase the efficiency of MMS by reducing the number of excision cycles required without compromising oncological safety?
Methodology:
Approximately 290 patients with histologically confirmed BCC will be enrolled at five German centres and randomly assigned to either standard MMS or MMS with upstream LC-OCT margin determination. In the intervention group, the excision margin will be specifically extended if a tumour is detected in the LC-OCT.
Primary endpoint:
Number of MMS cycles required to achieve R0 resection.
Secondary endpoints:
Total duration of surgery, size of surgical defect, cosmetic outcome (POSAS), patient satisfaction and stress, sensitivity and specificity of LC-OCT compared to histopathology.
Significance:
The study addresses the clinical conflict of objectives between complete tumour removal and maximum tissue preservation. Successful implementation could optimise MMS through modern imaging, conserve surgical resources and improve patient care in the long term.
Read the detailed description
Basal cell carcinoma (BCC) is the most common type of skin cancer worldwide and occurs predominantly in fair-skinned populations. In Germany, approximately one in three individuals will develop BCC during their lifetime. Although BCC rarely metastasizes, it shows locally destructive growth with irregular, finger-like extensions into surrounding tissue, which can make complete surgical removal challenging. The majority of tumors arise in the sun-exposed head and neck region.
Micrographic surgery (Mohs micrographic surgery, MMS) represents the gold standard treatment for high-risk BCC, as it allows complete margin control and offers the highest cure rates. However, MMS is often time-consuming and resource-intensive because multiple sequential excision stages may be required until histopathology confirms complete tumor removal (R0 resection). Preoperative estimation of tumor margins is usually based on clinical examination and dermoscopy with a standard safety margin of 2-3 mm. This approach may be inaccurate, particularly in tumors with subclinical extension, which can lead either to unnecessarily large excisions or to residual tumor tissue requiring additional surgical stages.
Non-invasive imaging techniques have increasingly been investigated to improve the preoperative assessment of BCC margins. Optical coherence tomography (OCT) and the more recently developed line-field confocal optical coherence tomography (LC-OCT) allow high-resolution, real-time imaging of the skin. These technologies enable visualization of skin structures with near-histological resolution and can detect characteristic morphological features of BCC in vivo. Previous studies have demonstrated good diagnostic accuracy of OCT and LC-OCT for the detection and subtyping of BCC and suggest that these methods may also be useful for defining tumor margins before surgery.
In particular, LC-OCT combines the advantages of conventional OCT with the cellular resolution of confocal microscopy, allowing both vertical and horizontal imaging of the skin at high resolution. This enables detailed visualization of tumor architecture and potentially facilitates the detection of subclinical tumor extensions beyond the clinically visible borders.
The present multicenter randomized controlled study aims to evaluate whether LC-OCT-guided preoperative margin assessment can improve the efficiency of MMS. In the intervention group, the lateral tumor margins are examined preoperatively using LC-OCT. If tumor structures are detected at the planned resection margin, the surgical margin is extended accordingly before the first excision step. MMS is then performed according to the standard surgical protocol with histopathological examination of the margins. In centers where available, excised tissue may additionally be examined postoperatively using ex vivo LC-OCT or confocal microscopy to correlate imaging findings with histopathology.
The study investigates whether this image-guided approach can reduce the number of surgical stages required to achieve complete tumor removal, while maintaining oncological safety. By enabling more accurate preoperative mapping of tumor margins, LC-OCT-guided surgery may improve surgical planning and increase the likelihood of complete excision in the first stage of MMS. In addition, improved margin delineation could allow more tissue-sparing surgery, potentially leading to smaller surgical defects and better cosmetic outcomes.
Overall, this study evaluates the clinical utility of integrating LC-OCT into the surgical workflow of MMS. The results may provide evidence for a more efficient and resource-conserving surgical strategy in the treatment of basal cell carcinoma while maintaining the high oncological safety standards of micrographic surgery.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Margin Mapping with Line-field confocal optical coherence tomography
- Keywords
- basal cell carcinoma, line-field confocal optical coherence tomography, BCC, LC-OCT, Mohs micrographic surgery, MMS, margin mapping, margin assessment, skin cancer, one stop shop
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Margin Mapping with Line-field confocal optical coherence tomographyDiagnostic test
Both groups undergo micrographically controlled excision (Mohs surgery) in accordance with standard procedure.
Surgical margins are examined histopathologically as usual (e.g. Tübingen cake, Munich method). If tumour remnants are detected, re-excision (MMS cycle) is performed until the tumour is completely removed (R0). The difference in the intervention group is that they will receive preoperative (and if available) postoperative margin mapping of the BCC before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (LC-OCT) | Experimental | Preoperative tumour margin assessment using LC-OCT with targeted extension of resection margins in cases where imaging reveals tumour evidence. Receives: Diagnostic Test: Margin Mapping with Line-field confocal optical coherence tomography |
| Control group (standard MMS) | No intervention | Conventional clinical/dermatoscopic margin determination, as is customary in everyday clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surgical excision cycles (MMS cycles) required until complete tumour removal
Primary endpoints: Number of surgical excision cycles (MMS cycles) required until complete tumour removal (R0 status). This target parameter is directly related to the main question of whether preoperative margin assessment using LC-OCT increases the efficiency of MMS.
A significant difference (e.g. fewer MMS cycles in the intervention group) would prove that the image-guided procedure is more effective.
Measured: On the day of surgery (Day 0), after the first histopathological margin assessment
Secondary outcomes (7)
Total duration of the surgical procedure
Total duration of the surgical procedure (in minutes)
→ Recorded from the incision to the end of the operation.
Measured: intraoperatively, on the day of surgery (Day 0)
Area of the surgical defect after complete tumour removal
Area of the surgical defect after complete tumour removal (in cm²)
→ Documented for the purpose of assessing tissue preservation.
Measured: after the last excision, before wound closure
Cosmetic outcome of the scar
Cosmetic outcome of the scar (e.g. using Patient and Observer Scar Assessment Scale (POSAS)). The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
All parameters should preferably be compared to normal skin on a comparable anatomic location.
→ Assessment after a defined post-operative period.
Measured: at follow-up 2, approx. week 6-12
Patient satisfaction
Patient satisfaction
→ Determined by validated questionnaire (e.g. Likert scale for subjective evaluation of the process and result). A 5-point Likert scale is a popular rating scale for surveys that uses five options to measure opinions, attitudes, or perceptions, typically ranging from "Strongly Disagree" to "Strongly Agree," with a neutral option in the middle.
Measured: week 6-12
Correlation between LC-OCT findings and histopathological margin status
Correlation between LC-OCT findings and histopathological margin status
→ Specification of sensitivity, specificity, positive and negative predictive value of LC-OCT.
Measured: within 7 days after surgery
Number of unexpected tumour detections in peripheral areas originally assessed as tumour-free
Number of unexpected tumour detections in peripheral areas originally assessed as tumour-free
→ Evaluation of the diagnostic reliability of LC-OCT.
Measured: within 7 days after surgery
Occurrence of complications or adverse events
Occurrence of complications or adverse events (e.g. delayed wound healing, infection)
→ To assess the safety of the procedure.
Measured: until completion of the second follow-up (i.e., by week 6-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2027 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Welzel, MD, Principal investigator, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482956
- Sponsor's protocol ID
- BCC-One-Stop-Study
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Interventional Prospective Study to Evaluate the Efficiency of Pre- and Postoperative Margin Determination of Basal Cell Carcinomas Using Optical Coherence Tomography and Line-field Confocal Optical Coherence Tomography During Micrographically Controlled Surgery
- ClinicalTrials.gov ID
- NCT07482956
- Acronym / sponsor ID
- BCC-One-Stop-Study
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, line-field confocal optical coherence tomography, BCC, LC-OCT, Mohs micrographic surgery, MMS, margin mapping, margin assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2026 (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.
Basal cell carcinoma (BCC) is the most common malignant skin tumour. The standard treatment is micrographically controlled surgery (MMS), which achieves high cure rates but requires considerable time and personnel. A key problem is the inadequate preoperative determination of tumour margins, which often leads to multiple cycles of excision.
The aim of this multicentre, prospective, randomised controlled intervention study is to evaluate line-field confocal optical coherence tomography (LC-OCT) for preoperative margin determination in BCC within the framework of MMS.
Research question:
Can preoperative LC-OCT-assisted margin marking increase the efficiency of MMS by reducing the number of excision cycles required without compromising oncological safety?
Methodology:
Approximately 290 patients with histologically confirmed BCC will be enrolled at five German centres and randomly assigned to either standard MMS or MMS with upstream LC-OCT margin determination. In the intervention group, the excision margin will be specifically extended if a tumour is detected in the LC-OCT.
Primary endpoint:
Number of MMS cycles required to achieve R0 resection.
Secondary endpoints:
Total duration of surgery, size of surgical defect, cosmetic outcome (POSAS), patient satisfaction and stress, sensitivity and specificity of LC-OCT compared to histopathology.
Significance:
The study addresses the clinical conflict of objectives between complete tumour removal and maximum tissue preservation. Successful implementation could optimise MMS through modern imaging, conserve surgical resources and improve patient care in the long term.
Detailed description
Basal cell carcinoma (BCC) is the most common type of skin cancer worldwide and occurs predominantly in fair-skinned populations. In Germany, approximately one in three individuals will develop BCC during their lifetime. Although BCC rarely metastasizes, it shows locally destructive growth with irregular, finger-like extensions into surrounding tissue, which can make complete surgical removal challenging. The majority of tumors arise in the sun-exposed head and neck region.
Micrographic surgery (Mohs micrographic surgery, MMS) represents the gold standard treatment for high-risk BCC, as it allows complete margin control and offers the highest cure rates. However, MMS is often time-consuming and resource-intensive because multiple sequential excision stages may be required until histopathology confirms complete tumor removal (R0 resection). Preoperative estimation of tumor margins is usually based on clinical examination and dermoscopy with a standard safety margin of 2-3 mm. This approach may be inaccurate, particularly in tumors with subclinical extension, which can lead either to unnecessarily large excisions or to residual tumor tissue requiring additional surgical stages.
Non-invasive imaging techniques have increasingly been investigated to improve the preoperative assessment of BCC margins. Optical coherence tomography (OCT) and the more recently developed line-field confocal optical coherence tomography (LC-OCT) allow high-resolution, real-time imaging of the skin. These technologies enable visualization of skin structures with near-histological resolution and can detect characteristic morphological features of BCC in vivo. Previous studies have demonstrated good diagnostic accuracy of OCT and LC-OCT for the detection and subtyping of BCC and suggest that these methods may also be useful for defining tumor margins before surgery.
In particular, LC-OCT combines the advantages of conventional OCT with the cellular resolution of confocal microscopy, allowing both vertical and horizontal imaging of the skin at high resolution. This enables detailed visualization of tumor architecture and potentially facilitates the detection of subclinical tumor extensions beyond the clinically visible borders.
The present multicenter randomized controlled study aims to evaluate whether LC-OCT-guided preoperative margin assessment can improve the efficiency of MMS. In the intervention group, the lateral tumor margins are examined preoperatively using LC-OCT. If tumor structures are detected at the planned resection margin, the surgical margin is extended accordingly before the first excision step. MMS is then performed according to the standard surgical protocol with histopathological examination of the margins. In centers where available, excised tissue may additionally be examined postoperatively using ex vivo LC-OCT or confocal microscopy to correlate imaging findings with histopathology.
The study investigates whether this image-guided approach can reduce the number of surgical stages required to achieve complete tumor removal, while maintaining oncological safety. By enabling more accurate preoperative mapping of tumor margins, LC-OCT-guided surgery may improve surgical planning and increase the likelihood of complete excision in the first stage of MMS. In addition, improved margin delineation could allow more tissue-sparing surgery, potentially leading to smaller surgical defects and better cosmetic outcomes.
Overall, this study evaluates the clinical utility of integrating LC-OCT into the surgical workflow of MMS. The results may provide evidence for a more efficient and resource-conserving surgical strategy in the treatment of basal cell carcinoma while maintaining the high oncological safety standards of micrographic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (LC-OCT) | Experimental | Diagnostic Test: Margin Mapping with Line-field confocal optical coherence tomographyPreoperative tumour margin assessment using LC-OCT with targeted extension of resection margins in cases where imaging reveals tumour evidence. |
| Control group (standard MMS) | No intervention | –Conventional clinical/dermatoscopic margin determination, as is customary in everyday clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) with basal cell carcinoma (BCC) scheduled for Mohs micrographic surgery (MMS),
- Diagnosis confirmed by dermoscopy and histopathology or optical coherence tomography (OCT),
- No limitation regarding tumor size or BCC subgroups.
Key exclusion criteria (4 listed)
- Poor LC-OCT image quality,
- Incomplete adherence to the study protocol,
- Previous treatment of the BCC,
- Anatomical sites that are difficult to access with LC-OCT (e.g., inner ear, medial canthus of the eye).
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 |
|---|---|---|
| Margin Mapping with Line-field confocal optical coherence tomographyBoth groups undergo micrographically controlled excision (Mohs surgery) in accordance with standard procedure. Surgical margins are examined histopathologically as usual (e.g. Tübingen cake, Munich method). If tumour remnants are detected, re-excision (MMS cycle) is performed until the tumour is completely removed (R0). The difference in the intervention group is that they will receive preoperative (and if available) postoperative margin mapping of the BCC before surgery. | Diagnostic test | Intervention group (LC-OCT) |
Primary outcome
Number of surgical excision cycles (MMS cycles) required until complete tumour removal
Time frame: On the day of surgery (Day 0), after the first histopathological margin assessment
Primary endpoints: Number of surgical excision cycles (MMS cycles) required until complete tumour removal (R0 status). This target parameter is directly related to the main question of whether preoperative margin assessment using LC-OCT increases the efficiency of MMS. A significant difference (e.g. fewer MMS cycles in the intervention group) would prove that the image-guided procedure is more effective.
7 secondary outcomes
Total duration of the surgical procedure
Time frame: intraoperatively, on the day of surgery (Day 0)
Area of the surgical defect after complete tumour removal
Time frame: after the last excision, before wound closure
Cosmetic outcome of the scar
Time frame: at follow-up 2, approx. week 6-12
Patient satisfaction
Time frame: week 6-12
Correlation between LC-OCT findings and histopathological margin status
Time frame: within 7 days after surgery
Number of unexpected tumour detections in peripheral areas originally assessed as tumour-free
Time frame: within 7 days after surgery
Occurrence of complications or adverse events
Time frame: until completion of the second follow-up (i.e., by week 6-12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Julia Welzel, MD principal investigator
University Hospital Augsburg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Margin Mapping with Line-field confocal optical coherence tomography in people with Basal Cell Carcinoma, run by University Hospital Augsburg at 5 sites in Germany.
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 4 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Welzel, MD (00498214007401, julia.welzel@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of surgical excision cycles (MMS cycles) required until complete tumour removal (time frame: On the day of surgery (Day 0), after the first histopathological margin assessment). 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 19 Mar 2026.