Two-photon Fluorescence Microscopy of Dermatologic Biopsies
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?
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michael G Giacomelli, Ph.D
- Telefonnummer: 5852766260
- E-post: mgiacome@ur.rochester.edu
Studiesteder
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New York
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Victor, New York, Forente stater, 14654
- Rekruttering
- Rochester Dermatologic Surgery
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Ta kontakt med:
- Sherrif Ibrahim, M.D.-Ph.D.
- Telefonnummer: 585-222-1400
- E-post: dr.ibrahim@rochesterdermsurgery.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Punch, excisional or shave biopsy specimen
Exclusion Criteria:
- Biopsies composed of multiple excisions or pieces
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: TPFM imaging of biopsy
Specimens will be imaged with TPFM
|
Ex vivo tissues will be imaged with two photon microscopy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Specificity of TPFM for prediction of the official patient diagnoses
Tidsramme: 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.
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After completion of patient diagnosis (typically 1-2 weeks after procedure)
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Sensitivity of TPFM for prediction of the official patient diagnoses
Tidsramme: 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.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity of Two Photon Fluorescence Microscopy
Tidsramme: After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
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.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
|
Specificity of two photon fluorescence microscopy
Tidsramme: After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
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.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00009823A
- R37CA258376 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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