Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Diagnostic Trial of a Vision Transformer-Based Ultrasound AI Model for Placenta Accreta Spectrum

8 juni 2026 uppdaterad av: FANG HE

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

This study develops an end-to-end Vision Transformer (ViT)-based artificial intelligence system for ultrasound-based diagnosis of placenta accreta spectrum (PAS), aiming to improve the accuracy and efficiency of prenatal screening using standardized ultrasound video inputs.

Studieöversikt

Status

Rekrytering

Betingelser

Placenta Accreta Spectrum

Intervention / Behandling

Diagnostiskt test: Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

561

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Fang He, M.D, PhD
Telefonnummer: +86 13724831279
E-post: Gzhefang@gzhmu.edu.cn

Studieorter

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina, 510150
    - Rekrytering
    - The Third Affiliated Hospital, Guangzhou Medical University
    - Kontakt:
      
      Fang He, MD, PhD
      
      Telefonnummer: +86 13724831279
      
      E-post: Gzhefang@gzhmu.edu.cn

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Pregnant women aged 18-45 years; Gestational age between 24 and 34 weeks; Pregnant women with a history of placenta previa or with an anterior placenta.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Diagnostic performance of the end-to-end Vision Transformer (ViT)-based ultrasound AI model for placenta accreta spectrum (PAS) Tidsram: At delivery (following confirmation of PAS status by surgical and/or pathological findings)	Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC) of the model.	At delivery (following confirmation of PAS status by surgical and/or pathological findings)

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Clinical Feasibility of the Standardized Ultrasound Video Recording Method Tidsram: At enrollment during the ultrasound examination	Completion Rate (Proportion of patients who successfully complete the standardized recording) and time consumption (Mean recording time)	At enrollment during the ultrasound examination
Consistency and Efficiency Between the AI Model and Physician Diagnosis Tidsram: At enrollment during the ultrasound examination	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).	At enrollment during the ultrasound examination
Safety of the AI Model Tidsram: At delivery, when PAS status and maternal outcomes are assessed	False Negative Rate: Proportion of missed PAS-positive patients and the impact on patient outcomes .	At delivery, when PAS status and maternal outcomes are assessed

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

FANG HE

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2025

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

2 juni 2026

Först inskickad som uppfyllde QC-kriterierna

8 juni 2026

Första postat (Faktisk)

11 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)