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Real-time Diagnosis of Diminutive Colorectal Polyps Using AI (COMET-OPTICAL)

2022年4月29日 更新者：Maastricht University Medical Center

Real Time Computer-aided Diagnosis (CADx) of Diminutive Colorectal Polyps Using Artificial Intelligence

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Artificial intelligence has great potential in image analysis in gastrointestinal endoscopy. Aim of this study is to investigate the real-time diagnostic performance of AI4CRP for the classification of diminutive colorectal polyps, and to compare it with the real-time diagnostic performance of commercially available CADx systems.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Despite additional training, even experienced endoscopists continue to fail meeting international thresholds set for safe implementation of treatment strategies based on optical diagnosis.

Multiple machine learning techniques - computer-aided diagnosis (CADx) systems - have been developed for applications in medical imaging within colonoscopy and can improve endoscopic classification of colorectal polyps.

Aim of this study is to explore the feasibility of the workflow using AI4CRP (a CNN based CADx system) real-time in the endoscopy suite, and to investigate the real-time diagnostic performance of AI4CRP for the diagnosis of diminutive (<5mm) colorectal polyps. Secondary, the real-time performance of commercially available CADx systems will be investigated and compared with AI4CRP performance.

研究の種類

観察的

入学 (予想される)

105

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • オランダ
    • Limburg
    • Noord-Brabant
      • Eindhoven、Noord-Brabant、オランダ、5623 EJ
        • 完了
        • Catharina Ziekenhuis Eindhoven

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patient receiving a colonoscopy because of regular care will be considered eligible for inclusion if at least one diminutive colorectal polyp is encountered during the colonoscopy. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases.

説明

Inclusion Criteria:

  • Age >18 years;
  • Patients with at least one colorectal polyps encountered during colonoscopy;
  • Patients referred for a colonoscopy by the Dutch bowel cancer screening program, patients undergoing a colonoscopy for endoscopic surveillance, or patients undergoing a colonoscopy because of complaints;
  • Written informed consent.

Exclusion Criteria:

  • Patients with prior history of inflammatory bowel diseases (IBD) or polyposis syndromes;
  • Patients with inadequate bowel preparations after adequate washing, suctioning, and cleaning manoeuvres have been performed by the endoscopist;
  • Patients undergoing an emergency colonoscopy;
  • Written objection in the patient file for participation in scientific research.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Gastroenterology patients

Patient receiving a colonoscopy because of regular care will be considered eligible for inclusion if at least one diminutive colorectal polyp is encountered during the colonoscopy. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases.

Colonoscopies will be executed using Fujifilm endoscopy systems (Fujifilm® Corporation, Tokyo, Japan), using Pentax endoscopy systems (Pentax Medical®, Hamburg, Germany), and using Olympus endoscopy systems (Olympus®, Tokyo, Japan).
デバイス：Computer-aided diagnosis (CADx) systems
  • AI4CRP (artificial intelligence for colorectal polyps), a CNN based computer-aided diagnosis system for diagnosis of colorectal polyps (COMET-OPTICAL research group);
  • CAD EYE, a computer-aided diagnosis system for diagnosis of colorectal polyps (Fujifilm® Corporation, Tokyo, Japan).
他の名前：
  • AI4CRP, artificial intelligence for colorectal polyps (COMET-OPTICAL research group)
  • CAD EYE (Fujifilm® Corporation, Tokyo, Japan)

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
Technical feasibility of real-time use of AI4CRP.
時間枠：6 months
The technical feasibility of real-time use of AI4CRP in the endoscopy suite regarding a proper reception of the video output from the local endoscopy processor towards AI4CRP (in high definition quality, without any delays in time).
6 months
User interface feasibility of real-time use of AI4CRP.
時間枠：6 months
The user interface feasibility of real-time use of AI4CRP in the endoscopy suite regarding a correct alignment of the user interface of AI4CRP with the video output from the local endoscopy system (resizing image pixels and anonymization).
6 months
The diagnostic accuracy of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
時間枠：1 year
The real-time diagnostic accuracy of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). Diagnostic accuracy defined as the percentage of correctly optically diagnosed colorectal polyps.
1 year
The sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
時間枠：1 year
The real-time sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
時間枠：1 year
The real-time specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
時間枠：1 year
The real-time negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
時間枠：1 year
The real-time positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
時間枠：1 year
The real-time Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
The diagnostic accuracy of AI4CRP per polyp.
時間枠：1 year
The real-time diagnostic accuracy of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The sensitivity of AI4CRP per polyp.
時間枠：1 year
The real-time sensitivity of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The specificity of AI4CRP per polyp.
時間枠：1 year
The real-time specificity of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The negative predictive value of AI4CRP per polyp.
時間枠：1 year
The real-time negative predictive value of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The positive predictive value of AI4CRP per polyp.
時間枠：1 year
The real-time positive predictive value of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The Area Under ROC Curve (AUC) of AI4CRP per polyp.
時間枠：1 year
The real-time Area Under ROC Curve (AUC) of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The diagnostic accuracy of CAD EYE in BLI mode, per polyp.
時間枠：1 year
The real-time diagnostic accuracy of CAD EYE in BLI mode, per polyp.
1 year
The sensitivity of CAD EYE in BLI mode, per polyp.
時間枠：1 year
The real-time sensitivity of CAD EYE in BLI mode, per polyp.
1 year
The specificity of CAD EYE in BLI mode, per polyp.
時間枠：1 year
The real-time specificity of CAD EYE in BLI mode, per polyp.
1 year
The negative predictive value of CAD EYE in BLI mode, per polyp.
時間枠：1 year
The real-time negative predictive value of CAD EYE in BLI mode, per polyp.
1 year
The positive predictive value of CAD EYE in BLI mode, per polyp.
時間枠：1 year
The real-time positive predictive value of CAD EYE in BLI mode, per polyp.
1 year
The Area Under ROC Curve (AUC) of CAD EYE in BLI mode, per polyp.
時間枠：1 year
The real-time Area Under ROC Curve (AUC) of CAD EYE in BLI mode, per polyp.
1 year
The diagnostic accuracy of AI4CRP per patient.
時間枠：1 year
The real-time diagnostic accuracy of AI4CRP per patient (in case of multiple polyps per patient).
1 year
The diagnostic accuracy of CAD EYE per patient.
時間枠：1 year
The real-time diagnostic accuracy of CAD EYE per patient (in case of multiple polyps per patient).
1 year
The localization score of AI4CRP.
時間枠：1 year
The localization score of AI4CRP regarding the number of images in which the heatmap produced by AI4CRP pointed out the area of interest (scale: correct, incorrect, or partly correct area of interest).
1 year
The difference in diagnostic accuracy of endoscopists per polyp before and after AI.
時間枠：1 year
The difference in real-time diagnostic accuracy of endoscopists per polyp before and after AI.
1 year
The difference in sensitivity of endoscopists per polyp before and after AI.
時間枠：1 year
The difference in real-time sensitivity of endoscopists per polyp before and after AI.
1 year
The difference in specificity of endoscopists per polyp before and after AI.
時間枠：1 year
The difference in real-time specificity of endoscopists per polyp before and after AI.
1 year
The difference in negative predictive value of endoscopists per polyp before and after AI.
時間枠：1 year
The difference in real-time negative predictive value of endoscopists per polyp before and after AI.
1 year
The difference in positive predictive value of endoscopists per polyp before and after AI.
時間枠：1 year
The difference in real-time positive predictive value of endoscopists per polyp before and after AI.
1 year
The agreement in surveillance interval based on optical diagnosis and histopathology.
時間枠：1 year
The agreement in surveillance interval based on optical diagnosis of diminutive colorectal polyps and histopathology of small and large colorectal polyps, compared to the surveillance interval based on histopathology of all colorectal polyps (diminutive, small, and large).
1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Maastricht University Medical Center

協力者

Catharina Ziekenhuis Eindhoven
Eindhoven University of Technology

捜査官

  • 主任研究者：Erik Schoon, Prof Dr MD、Maastricht Universitair Medisch Centrum

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年8月20日

一次修了 (予想される)

2022年9月1日

研究の完了 (予想される)

2022年12月1日

試験登録日

最初に提出

2022年3月31日

QC基準を満たした最初の提出物

2022年4月21日

最初の投稿 (実際)

2022年4月27日

学習記録の更新

投稿された最後の更新 (実際)

2022年5月5日

QC基準を満たした最後の更新が送信されました

2022年4月29日

最終確認日

2022年4月1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

  • METC2021-3036

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?

未定

IPD プランの説明

A data sharing plan is not yet decided on.

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米国FDA規制機器製品の研究

いいえ

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