Trial Outcomes & Findings for Investigation of Mohs Surgical Margins Using Two Photon Microscopy (NCT NCT05814900)
NCT ID: NCT05814900
Last Updated: 2026-04-02
Results Overview
Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard
COMPLETED
NA
135 participants
During Mohs surgery, typically less than 60 minutes
2026-04-02
Participant Flow
Withdrawal group was due to technical issues during frozen sectioning or specimen holder failure. The first 10 patients of the study (pre-study training) were used to develop procedures and train readers.
Participant milestones
| Measure |
Two-photon Fluorescence Microscopy (TPFM) Imaging of Surgical Margins
Patients will be imaged with two-photon fluorescence microscopy
|
|---|---|
|
Overall Study
STARTED
|
135
|
|
Overall Study
Withdrawal
|
3
|
|
Overall Study
Pre-study training
|
10
|
|
Overall Study
COMPLETED
|
135
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Mohs Surgical Margins Using Two Photon Microscopy
Baseline characteristics by cohort
| Measure |
Two-photon Fluorescence Microscopy Imaging of Surgical Margins
n=135 Participants
Patients will be imaged with two-photon fluorescence microscopy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
135 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During Mohs surgery, typically less than 60 minutesPopulation: Each patient may undergo multiple Mohs micrographic surgery staged excisions. 122 first stage excisions, 44 second stage excisions and 3 third stage excisions.
Sensitivity and specificity of two-photon fluorescence microscopy on Mohs surgical margins compared to frozen sections as gold standard
Outcome measures
| Measure |
TPFM Imaging of Surgical Margins
n=169 Mohs micrographic surgery excisions
Patients will be imaged with TPFM
|
|---|---|
|
Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins
Sensitivity
|
72.7 Percentage
Interval 57.2 to 85.0
|
|
Agreement Between Frozen Sections and Two Photon Fluorescence Microscopy on Mohs Margins
Specificity
|
96.8 Percentage
Interval 92.0 to 99.1
|
SECONDARY outcome
Timeframe: During Mohs surgery, typically less than 60 minutesPopulation: Each patient may undergo multiple Mohs micrographic surgery staged excisions. 122 first stage excisions, 44 second stage excisions and 3 third stage excisions.
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.
Outcome measures
| Measure |
TPFM Imaging of Surgical Margins
n=169 Mohs micrographic surgery excisions
Patients will be imaged with TPFM
|
|---|---|
|
Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts
Two-photon fluorescence microscopy specificity
|
97.8 Percentage
Interval 93.6 to 99.5
|
|
Specificity of Frozen Sections and Two-photon Fluorescence Microscopy Accounting for Errors Caused Frozen Section Artifacts
Frozen section specificity
|
91.1 Percentage
Interval 85.0 to 95.3
|
SECONDARY outcome
Timeframe: During Mohs surgery, typically less than 60 minutesPopulation: Each patient may undergo multiple Mohs micrographic surgery staged excisions. 122 first stage excisions, 44 second stage excisions and 3 third stage excisions.
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.
Outcome measures
| Measure |
TPFM Imaging of Surgical Margins
n=169 Mohs micrographic surgery excisions
Patients will be imaged with TPFM
|
|---|---|
|
Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis
Two-photon fluorescence microscopy sensitivity
|
97.1 Percentage
Interval 84.7 to 99.9
|
|
Sensitivity of Frozen Sections and Two-photon Fluorescence Microscopy on True Margin Diagnosis
Frozen section sensitivity
|
94.1 Percentage
Interval 80.3 to 99.3
|
Adverse Events
Two-photon Fluorescence Microscopy Imaging of Surgical Margins
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place