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?
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michael G Giacomelli, Ph.D
- 電話番号：5852766260
- メール：mgiacome@ur.rochester.edu
研究場所
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New York
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Victor、New York、アメリカ、14654
- 募集
- Rochester Dermatologic Surgery
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コンタクト：
- Sherrif Ibrahim, M.D.-Ph.D.
- 電話番号：585-222-1400
- メール：dr.ibrahim@rochesterdermsurgery.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Punch, excisional or shave biopsy specimen
Exclusion Criteria:
- Biopsies composed of multiple excisions or pieces
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TPFM imaging of biopsy
Specimens will be imaged with TPFM
|
Ex vivo tissues will be imaged with two photon microscopy
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Specificity of TPFM for prediction of the official patient diagnoses
時間枠：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.
|
After completion of patient diagnosis (typically 1-2 weeks after procedure)
|
|
Sensitivity of TPFM for prediction of the official patient diagnoses
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity of Two Photon Fluorescence Microscopy
時間枠：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
時間枠：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)
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00009823A
- R37CA258376 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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