白板症、扁平上皮癌、声帯ポリープ、声帯結節、上部気道消化管腫瘍、上部気道消化管 (UADT) 新生物の臨床試験-臨床試験登録-ICH GCP

調査の概要

状態

まだ募集していません

条件

詳細な説明

The artificial intelligence algorithms developed will be employed in the analysis of laryngeal lesions for 3 tasks:

Task 1: Computer aided diagnosis (CADx): the algorithm provides a differential diagnosis between benign and malignant neoplasms (binary classification) and the exact histology (multiclass classification). During the UADT video-endoscopy in the outpatient clinic, the physician performs the video-endoscopy and selects and captures n.3 WL and n.3 NBI significant frames of the lesion. The AI model records the classification output of the algorithm that the physician cannot access. The predicted pathologic results will be finally displayed as two different classifications along with the probability of each prediction (0% to 100%) as estimated by the AI algorithm: a first binary classification "neoplastic" or "non-neoplastic," and a second multiclass classification with the exact histology. The physician subsequently, based on the endoscopic examination, will write the suspected diagnosis (benign vs. malignant lesion and the actual histology) in the appropriate patient chart. Next, the physician reviews the screenshot taken and makes sure the lesion is visible in every one of them. Retrospectively, an investigator (blinded to the physician's assessment) will review the AI processed frames with the resulting CADx classifications and mark the AI-processed diagnosis in the patient chart. Once biopsied, the final histology of the lesion analyzed by definitive histopathological examination is recorded in the patient chart by the investigator. The investigators will finally compare the two recorded diagnoses (CADx and physician) with the definitive histology.
Task 2: Computer aided detection (CADe): the algorithm, through the representation of a rectangle (bounding box), localizes the lesion during the video-endoscopy in the outpatient clinic in real-time. During the UADT video-endoscopy, the physician performs the video-endoscopy as for standard-of-care procedure. In parallel, the AI model processes in real-time the endoscopic video and records the output of the algorithm (which the physician cannot access). The physician captures n.3 WL and n.3 NBI significant frames of the lesion. Moreover, n.3 frames where no lesions are visible are captured as negative controls. Later, the physician reviews the screenshot taken and makes sure to label the frames where the lesion is visible as "positive cases" and the frame where the lesion is not visible as "negative cases". The investigators will finally assess if the lesion was detected by the CADe system to define a "true positive". Similarly, to define a true negative, the CADe system should have not output a bounding box in the majority of the "negative cases" frames.
Task 3: Computer aided segmentation (CASe): the algorithm analyzes the neoplasm margins and provides a delineation mask. In the operating room setting, once the lesion to be resected is identified with a 0° telescope, the surgeon captures n.1 WL and n.1 NBI close-up photographs that exemplify the superficial lesion margins. The same procedure is repeated with a 70° optics and other two photographs are acquired. The frames taken are then saved and analyzed by the AI algorithm, which will perform the segmentation task. The surgeon will be blinded to the AI prediction. Later, the surgeon will draw the margins of the lesion according to her/his evaluation of each captured frame. The annotated frame will be saved so that it can be analyzed at a later time. Afterwards, in cases where positive superficial margins are identified by histopathologic examination, the surgeon-designed margins and the AI model ones will be compared to see if there was any difference in the suggested margin.

研究の種類

観察的

入学 (推定)

283

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

名前：Leonardo De Mattos, PhD
電話番号：+39 010 2898 270
メール：leonardo.demattos@iit.it

研究場所

イタリア
- GE
  - Genova、GE、イタリア、16131
    - IRCCS Ospedale Policlinico San Martino
    - コンタクト：
      
      Francesco Mora, Otorhinolaryngologist and Prof
      
      電話番号：+39 010-5557479
      
      メール：Francesco.Mora@unige.it
    - 主任研究者：
      
      Francesco Mora, MD PhD
スペイン
- Barcelona
  - Barcelona、Barcelona、スペイン、08036
    - Hospital Clinic de Barcelona
    - コンタクト：
      
      Claudio Sampieri, Otorhinolaryngologist
      
      電話番号：+34 93 227 57 66
      
      メール：claudio.sampieri@outlook.com
    - 主任研究者：
      
      Claudio Sampieri, MD PhD
ベルギー
- Flemish Brabant
  - Leuven、Flemish Brabant、ベルギー、3000
    - UZ Leuven
    - コンタクト：
      
      Vincent Vander Poorten, Prof. and ENT Surgeon
      
      電話番号：+32 16 33 23 42
      
      メール：vincent.vanderpoorten@uzleuven.be
    - 主任研究者：
      
      Vincent Vander Poorten, MD PhD

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

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The sample size for a single-arm, prospective cohort study, where the same group of patients undergoes testing with an AI model and a human physician and then they are compared with the gold standard reference test (biopsy) was calculated based on information from previous studies

説明

Inclusion Criteria:

Age > 18 years
Injury originating from the upper aero-digestive tract
Recording of the video-endoscopic examination
Patient known to undergo a biopsy of the lesion or clinical follow-up for lesion with known biopsy (e.g. laryngeal papillomatosis) or suffering from Reinke's edema (in this pathology, in fact, biopsy is not necessary since the diagnosis is clinical)
Or patients undergoing transoral lesion excision

Exclusion Criteria:

Submucosal lesion
Patients with previous operations on the upper aero-digestive tract
Patients with previous radiotherapy of the head and neck district
Poor compliance on endoscopic examination
Unavailability of CADe/CADx or CASe data logging note

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

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
Negative Predictive Value of the CADx Algorithm for Malignant or Premalignant Upper Aerodigestive Tract Lesions 時間枠：From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.	Negative Predictive Value (NPV) of the computer-aided diagnosis (CADx) algorithm for classifying UADT lesions as malignant/premalignant versus benign/non-neoplastic, using definitive histopathology as the reference standard. The CADx final classification will be based on the majority rule across selected white-light and narrow-band imaging frames. NPV = true negatives / (true negatives + false negatives). The pre-specified performance target is NPV ≥ 90%.	From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Sensitivity of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions 時間枠：At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.	Sensitivity of the computer-aided detection (CADe) algorithm for localizing UADT lesions with a bounding box. A true positive is defined as localization of the lesion area by a bounding box in the majority of physician-labeled lesion-positive captured frames. Sensitivity = true positives / (true positives + false negatives).	At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Median Intersection Over Union Between CASe Segmentation and Surgeon-Drawn Lesion Margins 時間枠：At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.	Median overlap between the AI-generated segmentation mask and the lesion margin area drawn by the surgeon on intraoperative endoscopic images. Intersection over Union (IoU) = area of overlap / area of union. Values range from 0 to 1; higher values indicate greater agreement.	At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.
Median Dice Similarity Coefficient Between CASe Segmentation and Surgeon-Drawn Lesion Margins 時間枠：At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.	Median Dice Similarity Coefficient (DSC) between the AI-generated segmentation mask and the lesion margin area drawn by the surgeon on intraoperative endoscopic images. Dice Similarity Coefficient = 2 × area of overlap / (AI segmented area + surgeon-drawn area). Values range from 0 to 1; higher values indicate greater agreement.	At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.

二次結果の測定

結果測定	メジャーの説明	時間枠
WL-NPV vs. NBI-NPV of CADx classification 時間枠：From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.	Negative Predictive Value (NPV) of CADx classification calculated using only the three selected white-light frames, compared with definitive histopathology, vs. NPV of CADx classification calculated using only the three selected narrow-band imaging frames, compared with definitive histopathology. The final AI-result will be calculated based on the majority rule of the 3 WL and 3 NBI frames computed separately.	From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Clinician-Reported Usability Score for the AI Endoscopy System 時間枠：Assessed after clinician use of the AI system during study procedures, up to 20 months after study initiation.	Usability of the AI endoscopy system assessed using standardized usability questionnaires administered to clinicians after use of the AI system. Questionnaire scoring will be interpreted according to the selected questionnaire manual, with higher scores indicating greater usability.	Assessed after clinician use of the AI system during study procedures, up to 20 months after study initiation.
Sensitivity, Specificity and Accuracy of CADx histology prediction 時間枠：From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.	Sensitivity, Specificity and Accuracy of the CADx algorithm for histology prediction, compared with definitive histopathology.	From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
F1 Score of CADx Classification 時間枠：From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.	F1 score of the CADx classification output compared with definitive histopathology.	From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Area Under the Receiver Operating Characteristic Curve of CADx Classification 時間枠：From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.	AUC of the ROC curve for CADx classification of UADT lesions compared with definitive histopathology.	From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Sensitivity, Specificity and Accuracy of human physician histology prediction 時間枠：From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.	Sensitivity, Specificity an Accuracy of the treating physician's suspected diagnosis compared with definitive histopathology.	From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy.
Specificity of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions 時間枠：At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.	Proportion of physician-labeled lesion-negative frames/cases in which the CADe algorithm does not output a bounding box in the majority of negative-control frames.	At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Accuracy of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions 時間枠：At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.	Overall proportion of correctly classified lesion-positive and lesion-negative cases/frames by the CADe algorithm.	At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Positive Predictive Value of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions 時間枠：At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.	Positive predictive value of CADe bounding-box output for lesion localization. PPV = true positives / (true positives + false positives).	At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Negative Predictive Value of the CADe Algorithm for Localization of Upper Aerodigestive Tract Lesions 時間枠：At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.	Negative predictive value of CADe absence of bounding-box output for lesion localization. NPV = true negatives / (true negatives + false negatives).	At index outpatient UADT video-endoscopy, with blinded post-processing assessment performed up to 30 days after endoscopy.
Percentage of Positive Superficial Margin Cases in Which the AI-Predicted Tumor Area Is Wider Than the Surgeon-Drawn Area 時間枠：At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.	Among cases with positive superficial margins on final histopathology, percentage of cases in which the AI-predicted tumor area extends beyond the surgeon-drawn margin at the affected margin.	At intraoperative pre-resection endoscopy, with assessment performed after image annotation up to 30 days after surgery.

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

Istituto Italiano di Tecnologia

協力者

Universitaire Ziekenhuizen KU Leuven

Hospital Clinic of Barcelona

Universita degli Studi di Genova

CRO "Centro Clinical Trials" IRCCS Ospedale Policlinico San Martino

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Scuola Superiore Sant'Anna di Pisa

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (推定)

2026年5月1日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2028年2月1日

試験登録日

最初に提出

2026年5月5日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月19日

QC基準を満たした最後の更新が送信されました

2026年5月12日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

IIT_AIRCARE_H&NANCE

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

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

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions (H&NANCE)

Head&Neck Application of Novel Computer-assisted Endoscopy