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?
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Michael G Giacomelli, Ph.D
- 전화번호: 5852766260
- 이메일: mgiacome@ur.rochester.edu
연구 장소
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New York
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Victor, New York, 미국, 14654
- 모병
- Rochester Dermatologic Surgery
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연락하다:
- Sherrif Ibrahim, M.D.-Ph.D.
- 전화번호: 585-222-1400
- 이메일: dr.ibrahim@rochesterdermsurgery.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Punch, excisional or shave biopsy specimen
Exclusion Criteria:
- Biopsies composed of multiple excisions or pieces
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: TPFM imaging of biopsy
Specimens will be imaged with TPFM
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Ex vivo tissues will be imaged with two photon microscopy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Specificity of TPFM for prediction of the official patient diagnoses
기간: After completion of patient diagnosis (typically 1-2 weeks after procedure)
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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
기간: After completion of patient diagnosis (typically 1-2 weeks after procedure)
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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.
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After completion of patient diagnosis (typically 1-2 weeks after procedure)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sensitivity of Two Photon Fluorescence Microscopy
기간: After completion of patient diagnosis (typically 1-2 weeks after procedure)
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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.
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After completion of patient diagnosis (typically 1-2 weeks after procedure)
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Specificity of two photon fluorescence microscopy
기간: 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)
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00009823A
- R37CA258376 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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