Machine Learning Analysis of Two-photon Fluorescence Microscopy of Dermatologic Biopsies
Machine Learning Analysis of Expanded Two-photon Imaging of Skin Biopsy Specimens
The goal of this study is to investigate the ability of a machine learning model to evaluate two-photon fluorescence microscopy images of dermatologic biopsies at point of care.
The main question it aims to answer is:
• How well do two-photon fluorescence images of biopsies taken in a clinic and evaluated by a machine learning model agree with conventional histology?
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study will image biopsy specimens at point of care using two-photon fluorescence microscopy (TPFM) and then assess how well the images predict the eventual clinical diagnosis using 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 dermatology clinic will be imaged using TPFM shortly after biopsy procedures. Immediately following imaging, a machine learning model will evaluate the TPFM images then compute a confidence score for a diagnosis of basal cell carcinoma (BCC), squamous cell carcinoma, and non-cancer. The relative confidence in each diagnosis will be compared, and if sufficient confidence is achieved, the model will render a diagnosis or else flag the specimen as indeterminate for manual pathologist review. This workflow will evaluate the use of ML + TPFM to perform point of care diagnosis of skin lesions.
Following TPFM imaging, the specimen will be submitted for histological processing, which will guide actual patient treatment. Following conclusion of patient treatment, the resulting histology slides will be scanned for comparison and the final patient diagnosis recorded. Images of the histology slides will be read by a pathologist to establish a gold-standard diagnosis. The official diagnosis and the diagnosis from the collaborating pathologist will be compared.
Patient treatment will still be decided by conventional histopathology. TPFM will not be used to change treatment.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michael Giacomelli, Ph.D
- Número de telefone: 5852766260
- E-mail: mgiacome@ur.rochester.edu
Locais de estudo
-
-
New York
-
Victor, New York, Estados Unidos, 14654
- Recrutamento
- Rochester Dermatologic Surgery
-
Contato:
- Sherrif Ibrahim, M.D.-Ph.D.
- Número de telefone: 585-222-1400
- E-mail: dr.ibrahim@rochesterdermsurgery.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Punch, excisional or shave biopsy specimen
Exclusion Criteria:
- Biopsy indication includes melanoma or dysplastic/atypical nevus
- Excision thickness of less than 1 mm
- Excision longest dimension less than 2 mm
- Excision performed as multiple pieces in a single specimen container
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: TPFM imaging of biopsy
Specimens will be imaged with TPFM and diagnosed using a machine learning model
|
Ex vivo tissues will be imaged with two-photon microscopy and analyzed with machine learning for diagnosis
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sensitivity of Machine Learning Analysis of Two Photon Fluorescence Microscopy Images At Point of Care
Prazo: During or immediately following patient biopsy (same day)
|
A machine learning model will evaluate TPFM images of patient biopsies at point of care.
Sensitivity will be calculated for the machine learning model using two photon fluorescence microscopy images.
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 machine learning model provides a definitive diagnosis.
The patient's ultimate clinical diagnosis will serve as the reference standard.
|
During or immediately following patient biopsy (same day)
|
|
Specificity of Machine Learning Analysis of Two Photon Fluorescence Microscopy Images At Point of Care
Prazo: During or immediately following patient biopsy (same day)
|
A machine learning model will evaluate TPFM images of patient biopsies at point of care.
Specificity will be calculated for the machine learning model using two photon fluorescence microscopy images.
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 machine learning model provides a definitive diagnosis.
The patient's ultimate clinical diagnosis will serve as the reference standard.
|
During or immediately following patient biopsy (same day)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of Discordant Diagnoses Attributable to Machine Learning Model Interpretation Errors
Prazo: After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
For biopsy specimens with discordant diagnoses between the machine learning model and the patient's ultimate clinical diagnosis, a dermatopathologist will review each case and classify the source of disagreement as machine learning model interpretation error, image quality limitation, or image coregistration error.
The proportion of discordant diagnoses attributable to each source of disagreement will be reported.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
|
Proportion of Biopsy Specimens With a Definitive Machine Learning Diagnosis
Prazo: During or immediately following patient biopsy (same day)
|
The proportion of biopsy specimens for which the machine learning model provides a definitive diagnosis based on two photon fluorescence microscopy images will be calculated as the number of specimens receiving a definitive diagnosis divided by the total number of specimens evaluated.
|
During or immediately following patient biopsy (same day)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00009823B
- R37CA258376 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .