Diagnostic Trial of a Vision Transformer-Based Ultrasound AI Model for Placenta Accreta Spectrum
Diagnostic Trial of Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model for Assisting in the Diagnosis of Placenta Accreta Spectrum Disorders: An Investigator-Initiated Prospective Clinical Study
調査の概要
状態
詳細な説明
Placenta accreta spectrum (PAS) is a life-threatening obstetric disorder involving abnormal placental invasion into the uterine wall, which is associated with severe maternal and neonatal complications. Despite advances in imaging, prenatal diagnosis remains challenging due to variability in ultrasound interpretation and reliance on operator expertise.
This study will establish a standardized ultrasound video acquisition protocol and develop a deep learning-based model using Vision Transformer (ViT) architecture to process dynamic ultrasound sequences. The model will be trained using clinically confirmed postpartum outcomes as reference labels.
The diagnostic performance of the system will be systematically evaluated, with the goal of improving consistency in interpretation and supporting more efficient clinical decision-making in prenatal PAS screening.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Fang He, M.D, PhD
- 電話番号：+86 13724831279
- メール：Gzhefang@gzhmu.edu.cn
研究場所
-
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Guangdong
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Guangzhou、Guangdong、中国、510150
- 募集
- The Third Affiliated Hospital, Guangzhou Medical University
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コンタクト：
- Fang He, MD, PhD
- 電話番号：+86 13724831279
- メール：Gzhefang@gzhmu.edu.cn
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
- Pregnant women aged between 18 and 45 years;
- Gestational age between 24 and 34 weeks;
- Pregnant women with a history of placenta previa;
- Pregnant women with an anterior placenta;
- Willingness to participate in the study and provision of written informed consent.
Exclusion criteria:
- Failure to provide written informed consent;
- Presence of severe complications that precluded continuation of pregnancy;
- Inability to comply with study procedures for other reasons.
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
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 |
|---|---|---|
|
Diagnostic performance of the end-to-end Vision Transformer (ViT)-based ultrasound AI model for placenta accreta spectrum (PAS)
時間枠：At delivery (following confirmation of PAS status by surgical and/or pathological findings)
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Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC) of the model.
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At delivery (following confirmation of PAS status by surgical and/or pathological findings)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Feasibility of the Standardized Ultrasound Video Recording Method
時間枠：At enrollment during the ultrasound examination
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Completion Rate (Proportion of patients who successfully complete the standardized recording) and time consumption (Mean recording time)
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At enrollment during the ultrasound examination
|
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Consistency and Efficiency Between the AI Model and Physician Diagnosis
時間枠：At enrollment during the ultrasound examination
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Diagnostic Consistency: Kappa coefficient used to evaluate the consistency between the AI model's diagnoses and those of experienced ultrasound physicians (Kappa > 0.75 indicates good agreement).
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At enrollment during the ultrasound examination
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Safety of the AI Model
時間枠：At delivery, when PAS status and maternal outcomes are assessed
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False Negative Rate: Proportion of missed PAS-positive patients and the impact on patient outcomes .
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At delivery, when PAS status and maternal outcomes are assessed
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協力者と研究者
スポンサー
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
その他の研究ID番号
- Ethics Review NO. 286A01
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?
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
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。