Basal Cell Carcinoma of SkinNCT07773688
Two-photon Fluorescence Microscopy of Dermatologic Biopsies
A study testing Two photon microscopy imaging in people with Basal Cell Carcinoma of Skin and Squamous Cell Carcinoma, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this study is to investigate the ability of two-photon fluorescence microscopy to evaluate dermatologic biopsies. The main questions it aims to answer are: How well do two-photon fluorescence images of biopsies taken in a clinic and evaluated by a pathologist agree with conventional histology? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma, Melanocytic Lesion, Adult
- 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
- 644 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Apr 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Punch, excisional or shave biopsy specimen
Who cannot join
- Biopsies composed of multiple excisions or pieces
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
Rochester Dermatologic Surgery
Victor, New York, 14654
Sherrif Ibrahim, M.D.-Ph.D., 585-222-1400, dr.ibrahim@rochesterdermsurgery.com
About this study
Official title: Expanded Two-photon Imaging of Skin Biopsy Specimens
The goal of this study is to investigate the ability of two-photon fluorescence microscopy to evaluate dermatologic biopsies. The main questions it aims to answer are:
- How well do two-photon fluorescence images of biopsies taken in a clinic and evaluated by a pathologist agree with conventional histology?
Read the detailed description
This study will image biopsy specimens using two-photon fluorescence microscopy (TPFM) and then assess how well the images predict the eventual clinical diagnosis using both an expert pathologist and a machine learning model. Because two-photon images can be acquired from small biopsy specimens within minutes of excision, they could potentially be used to immediately diagnose patients, but the accuracy of TPFM for various skin conditions is unknown.
Individual biopsy specimens in a clinic lab will be imaged using TPFM. Following histological processing and patient treatment, resulting histology slides will be scanned for comparison. Images of the histology slides will be read by a pathologist to establish a gold-standard diagnosis and the official diagnosis will be recorded. TPFM images will be evaluated by a pathologist and concordance with the gold-standard determined.
- Being tested
- Two photon microscopy imaging
- Keywords
- two-photon microscopy
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two photon microscopy imagingDevice
Ex vivo tissues will be imaged with two photon microscopy
| Study group | Role | What they receive |
|---|---|---|
| TPFM imaging of biopsy | Experimental | Specimens 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.
Specificity of TPFM for prediction of the official patient diagnoses
Specificity is defined as the number of true negative diagnoses divided by the sum of true negative and false positive diagnoses among biopsy specimens for which the pathologist returned a definitive diagnosis. The patient's ultimate clinical diagnosis will serve as the reference standard.
Measured: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Sensitivity of TPFM for prediction of the official patient diagnoses
Sensitivity is defined as the number of true positive diagnoses divided by the sum of true positive and false negative diagnoses among biopsy specimens for which the pathologist returns a definitive diagnosis.
Measured: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Secondary outcomes (2)
Sensitivity of Two Photon Fluorescence Microscopy
Sensitivity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined. Sensitivity is defined as the number of true positive diagnoses divided by the sum of true positive and false negative diagnoses among biopsy specimens for which there is a definitive diagnosis. A subsequent read of the corresponding conventional histology images after a delay for washout will serve as the ground truth.
Measured: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Specificity of two photon fluorescence microscopy
Specificity of two photon fluorescence microscopy images read by a pathologist blinded to the true diagnosis will be determined. Specificity is defined as the number of true negative diagnoses divided by the sum of true negative and false positive diagnoses among biopsy specimens for which there is a definitive diagnosis. A subsequent read of the corresponding conventional histology images by the same pathologist after a delay for washout will serve as the ground truth.
Measured: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jun 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (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 Carcinoma of SkinStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 644 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rochester Dermatologic Surgery
- Responsible party
- Principal investigator, Michael Giacomelli, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773688
- Sponsor's protocol ID
- STUDY00009823A
- Other IDs
- R37CA258376
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified sets of two-photon images and corresponding conventional histology will be made available upon request. Links to full resolution image data will be included in publications.
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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Two-photon Imaging of Skin Biopsy Specimens
- ClinicalTrials.gov ID
- NCT07773688
- Acronym / sponsor ID
- STUDY00009823A
- Keywords
- two-photon microscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 644 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rochester Dermatologic Surgery
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 Aug 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.
The goal of this study is to investigate the ability of two-photon fluorescence microscopy to evaluate dermatologic biopsies. The main questions it aims to answer are:
- How well do two-photon fluorescence images of biopsies taken in a clinic and evaluated by a pathologist agree with conventional histology?
Detailed description
This study will image biopsy specimens using two-photon fluorescence microscopy (TPFM) and then assess how well the images predict the eventual clinical diagnosis using both an expert pathologist and a machine learning model. Because two-photon images can be acquired from small biopsy specimens within minutes of excision, they could potentially be used to immediately diagnose patients, but the accuracy of TPFM for various skin conditions is unknown.
Individual biopsy specimens in a clinic lab will be imaged using TPFM. Following histological processing and patient treatment, resulting histology slides will be scanned for comparison. Images of the histology slides will be read by a pathologist to establish a gold-standard diagnosis and the official diagnosis will be recorded. TPFM images will be evaluated by a pathologist and concordance with the gold-standard determined.
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 biopsy | Experimental | Device: Two photon microscopy imagingSpecimens will be imaged with TPFM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Punch, excisional or shave biopsy specimen
Key exclusion criteria (1 listed)
- Biopsies composed of multiple excisions or pieces
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 imagingEx vivo tissues will be imaged with two photon microscopy | Device | TPFM imaging of biopsy |
Primary outcome
Specificity of TPFM for prediction of the official patient diagnoses
Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Specificity is defined as the number of true negative diagnoses divided by the sum of true negative and false positive diagnoses among biopsy specimens for which the pathologist returned a definitive diagnosis. The patient's ultimate clinical diagnosis will serve as the reference standard.
Sensitivity of TPFM for prediction of the official patient diagnoses
Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Sensitivity is defined as the number of true positive diagnoses divided by the sum of true positive and false negative diagnoses among biopsy specimens for which the pathologist returns a definitive diagnosis.
2 secondary outcomes
Sensitivity of Two Photon Fluorescence Microscopy
Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Specificity of two photon fluorescence microscopy
Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)
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 Aug 2026.
- 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: Yes. Deidentified sets of two-photon images and corresponding conventional histology will be made available upon request. Links to full resolution image data will be included in publications.
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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.
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 of Skin and Squamous 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 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: looking for participants now, as of the sponsor's last update on 19 Aug 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 Michael G Giacomelli, Ph.D (5852766260, mgiacome@ur.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of TPFM for prediction of the official patient diagnoses (time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)). The study lists 2 primary outcomes in all. 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 NCT07773688, 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 19 Aug 2026.