Clinical trial · Interventional
Two-photon Fluorescence Microscopy of Dermatologic Biopsies
Expanded Two-photon Imaging of Skin Biopsy Specimens
NCT07773688CI-TRIAL-00122646recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma of Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Melanocytic Lesion, Adult | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Two photon microscopy imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPFM imaging of biopsy
- description
- Specimens will be imaged with TPFM
- interventionNames
- Device: Two photon microscopy imaging
Primary outcomes (2)
- measure
- Specificity of TPFM for prediction of the official patient diagnoses
- timeFrame
- After completion of patient diagnosis (typically 1-2 weeks after procedure)
- description
- 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.
- measure
- Sensitivity of TPFM for prediction of the official patient diagnoses
- timeFrame
- After completion of patient diagnosis (typically 1-2 weeks after procedure)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Punch, excisional or shave biopsy specimen Exclusion Criteria: * Biopsies composed of multiple excisions or pieces
References
Publications (1)
- BACKGROUNDChing-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. PMID 36069886