An interventional study of Two photon microscopy imaging in Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma and Melanocytic Lesion, Adult, sponsored by University of Rochester. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by University of Rochester · Not applicable, Interventional, and Diagnostic
Among 171 studies in Carcinoma, Basal Cell with a site in United States — 23 open to participants now, 38 under way, 2 of them phase 3. Carcinoma, Basal Cell · United States.
Among the 171 studies in Carcinoma, Basal Cell with a site in United States, this one is the 6th largest by planned enrollment of the 139 interventional ones, is one of 10 that started in 2026, is one of 37 with no phase, reaches primary completion later than 28 of the 37 other live ones, and was the 171st registered.
389 studies on the registry are indexed under Carcinoma, Basal Cell; 69 are open to participants now.
This study's planned enrollment of 644 is above the median of 50 across 272 interventional studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →23 of the 171 studies in Carcinoma, Basal Cell with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 52 Carcinoma, Basal Cell studies recruiting now, 48 (92%) set no upper age limit and 0 (0%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →171 studies; the count open now beside each. This study's row is marked.
First in 1977; this study’s year is marked. 10 started in 2026.
Median enrollment 40 across the 139 interventional studies, 80 across the 26 observational. Of the 119 that completed or were terminated, 48 (40%) have results posted.
57 of 171 have an industry lead sponsor. The 10 most frequent:
University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
University of Rochester has 4 studies filed under Carcinoma, Basal Cell — fewer than ten, so there is no comparison to draw.
19 of the studies in Carcinoma, Basal Cell with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06608511University of Wisconsin, MadisonLiquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers | 2026-12 |
| NCT06623201Nathalie ZeitouniBlue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas | 2026-12-01 |
| NCT04616248University of Southern CaliforniaIn Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors | 2027-01-09 |
| NCT06384924Tiezhi ZhangRaman Spectroscopy and Skin Cancer | 2027-02-13 |
| NCT05294120Memorial Sloan Kettering Cancer CenterA Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma | 2027-03 |
Among the 171 studies in Carcinoma, Basal Cell with a site in United States, from their registry updates:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Specimens will be imaged with TPFM
Device: Two photon microscopy imaging
Ex vivo tissues will be imaged with two photon microscopy
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.
Time frame: 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.
Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)
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.
Time frame: 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.
Time frame: After completion of patient diagnosis (typically 1-2 weeks after procedure)
Plan to share: 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.
Supporting information: Study protocol
Started Jun 2026 (actual). Primary completion is estimated for Apr 2028, 22 months after the start.
Of 50 interventional studies with no phase under Carcinoma, Basal Cell, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
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