Basal Cell CarcinomaNCT07182240
Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas
A study testing LC-OCT Imaging in people with Basal Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC). 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?
- LC-OCT Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to 22 Jun 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
- Age ≥ 18 years
- Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.
- Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.
- The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.
Who cannot join
- Known or reported allergy to mineral oil, the optical agent used during imaging.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- . Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
- Unwilling or unable to follow protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
About this study
To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).
- Conditions
- Basal Cell Carcinoma
- Being tested
- LC-OCT Imaging
- 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.
LC-OCT ImagingDevice
handheld imaging device will take high resolution images of lesion
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT) | Other | LC-OCT imaging Receives: Device: LC-OCT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with fully evaluable images
cases were the image evaluator can assess the margins based on image quality
Measured: 1.5 years
Secondary outcomes (5)
Patient interest in study
Will be measured by documenting the number of patients offered study participation and the number choosing to participate in the study
Measured: 1.5 years
Patients overall experience
Collect a 3-question questionnaire to document patients experience.
Measured: one office visit - immediately after imaging procedure
Determine LC-OCT imaging's impact on surgical workflow
Will be assessed by results of imaging assessment questionnaire given to surgeon
Measured: To be filled out immediately after finishing Mohs procedure
Accuracy of LC-OCT findings
Will be evaluated by Comparing LC-OCT findings with frozen section histopathological results
Measured: 1.5 years
Accuracy of LC-OCT in detectng location of tumor
will be evaluated by comparing the location of the LC-OCT reported margin positivity to the Mohs map
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start22 Dec 2025
- Primary completion22 Jun 2027 (estimated)
- Study completion22 Jun 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.
- More trials run by Roswell Park Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cerrene Giordano, MD, Principal investigator, Roswell Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182240
- Sponsor's protocol ID
- I-3839125
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas
- ClinicalTrials.gov ID
- NCT07182240
- Acronym / sponsor ID
- I-3839125
- Conditions
- Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 22 Jun 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 19 Sep 2025 (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.
To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT) | Other | Device: LC-OCT ImagingLC-OCT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.
- Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.
- The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.
Key exclusion criteria (4 listed)
- Known or reported allergy to mineral oil, the optical agent used during imaging.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- . Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.
- Unwilling or unable to follow protocol requirements
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 |
|---|---|---|
| LC-OCT Imaginghandheld imaging device will take high resolution images of lesion | Device | Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT) |
Primary outcome
Number of cases with fully evaluable images
Time frame: 1.5 years
cases were the image evaluator can assess the margins based on image quality
5 secondary outcomes
Patient interest in study
Time frame: 1.5 years
Patients overall experience
Time frame: one office visit - immediately after imaging procedure
Determine LC-OCT imaging's impact on surgical workflow
Time frame: To be filled out immediately after finishing Mohs procedure
Accuracy of LC-OCT findings
Time frame: 1.5 years
Accuracy of LC-OCT in detectng location of tumor
Time frame: 1.5 years
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 24 Sep 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.
Cerrene Giordano, MD principal investigator
Roswell Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LC-OCT Imaging in people with Basal Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 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 United States. 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 Ask RPCI (1-800-767-9355, askrpc@Roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases with fully evaluable images (time frame: 1.5 years). 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 24 Sep 2026.