Basal Cell CarcinomaNCT05814900
Investigation of Mohs Surgical Margins Using Two Photon Microscopy
A study testing Two photon microscopy imaging in people with Basal Cell Carcinoma, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is: How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology 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?
- Two photon microscopy imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Undergoing treatment for BCC with Mohs surgery at the performance site
- Able to read and understand consent form
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Dermatologic Surgery
Victor, New York, 14654
About this study
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:
- How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology
Read the detailed description
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H\&E slides, thus all patients will receive standard of care confirmation following experimental imaging.
Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Two photon microscopy 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.
Two photon microscopy imagingDevice
Excised tissues will be imaged with two photon microscopy
| Study group | Role | What they receive |
|---|---|---|
| TPFM imaging of surgical margins | Experimental | Patients will be imaged with TPFM Receives: Device: Two photon microscopy imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins
Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard
Measured: During Mohs surgery, typically less than 60 minutes
Secondary outcomes (2)
Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts
Calculation of specificity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially positive on frozen section margins but negative on two-photon fluorescence microscopy because cryosectioning to produce a flat slide has sectioned 100s of microns deeper into the margin and into the tumor is counted as a false positive for frozen section.
Measured: During Mohs surgery, typically less than 60 minutes
Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis
Calculation of sensitivity using frozen sections as the gold standard but accounting for frozen section artifacts that lead to incorrect treatment outcome. For example, initially negative on frozen section margins but positive on TPFM because a cryosectioning artifact has removed the area of pathology are counted as false negative on frozen sections.
Measured: During Mohs surgery, typically less than 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Jun 2023
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University of RochesterThe 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester Dermatologic Surgery
- Responsible party
- Principal investigator, Michael Giacomelli, University of Rochester
- Investigators
- Michael G Giacomelli, Ph.D, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814900
- Sponsor's protocol ID
- STUDY00008153
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2023
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.
PubMed 36069886
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Mohs Surgical Margins Using Two Photon Microscopy
- ClinicalTrials.gov ID
- NCT05814900
- Acronym / sponsor ID
- STUDY00008153
- Conditions
- Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Rochester Dermatologic Surgery
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:
- How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology
Detailed description
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H\&E slides, thus all patients will receive standard of care confirmation following experimental imaging.
Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPFM imaging of surgical margins | Experimental | Device: Two photon microscopy imagingPatients will be imaged with TPFM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing treatment for BCC with Mohs surgery at the performance site
- Able to read and understand consent form
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Two photon microscopy imagingExcised tissues will be imaged with two photon microscopy | Device | TPFM imaging of surgical margins |
Primary outcome
Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins
Time frame: During Mohs surgery, typically less than 60 minutes
Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard
2 secondary outcomes
Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts
Time frame: During Mohs surgery, typically less than 60 minutes
Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis
Time frame: During Mohs surgery, typically less than 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36069886Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.
- 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. This study is not recruiting at the moment.
Michael G Giacomelli, Ph.D principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two photon microscopy imaging in people with Basal Cell Carcinoma, run by University of Rochester 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 2 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: finished, as of the sponsor's last update on 2 Apr 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?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins (time frame: During Mohs surgery, typically less than 60 minutes). 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 NCT05814900, 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 2 Apr 2026.