An AI-Assisted Agentic System for Ultrasound Scanning and Diagnosis of Ovarian Lesions

NCT07801209 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-09-03

No results posted yet for this study

Summary

Investigators developed an interactive agentic system designed to guide newly qualified sonographers in ovarian lesion scanning and improve their scanning quality and diagnostic performance toward expert-level standards. Our agentic system is capable of capturing key features including the max-diameter plane of ovarian lesions from dynamic ultrasound videos, translating these findings into standardized International Ovarian Tumor Analysis (IOTA) descriptors, and providing multi-turn guidance for subsequent scanning, and ultimately generating an AI-assisted diagnostic assessment based on embedded expert knowledge.

In this multicenter study, participants are asked to undergo gynecological ultrasonography performed by sonographers with less than 3 years of experience with or without AI assistance. Our researchers will compare the performance of operators working with AI against that of operators working without AI, as well as against the performance of expert sonographers, to see whether AI assistance enhances the proficiency of less experienced operators and help them approach the scanning quality and diagnostic accuracy of expert sonographers in real-world clinical scenarios.

Conditions

  • Ovarian Mass
  • Adnexal Mass

Interventions

OTHER

non-AI assisted and then AI assisted

Participants first undergo ultrasound scanning and diagnosis by a junior sonographer without AI assistance, followed by ultrasound scanning by the same sonographer with AI assistance.

OTHER

AI assisted and then non-AI assisted

Participants first undergo ultrasound scanning and diagnosis by a junior sonographer with AI assistance, followed by ultrasound scanning by another junior sonographer without AI assistance. The two junior sonographers are blinded to each other's scanning and assessment results.

Sponsors & Collaborators

  • Shaoxing Maternity and Child Health Care Hospital

    collaborator OTHER
  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-19
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801209 on ClinicalTrials.gov