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NCT Number: NCT07801209

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

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.

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Key information

Conditions

Ovarian Mass Adnexal Mass

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Women's Hospital School Of Medicine Zhejiang University, Hangzhou, Zhejiang, China

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About this study

This multicenter, prospective study will be conducted at tertiary cancer centers and primary healthcare institutions across China. Participants will be recruited from gynecological ultrasound clinics of each site.

Each participant will undergo gynecological ultrasonography under both AI-assisted and unassisted conditions according to their group allocation. Following completion of the study examinations, expert sonographers with more than 10 years of experience, blinded to the scanning and diagnostic results of the junior sonographers, will independently perform a repeat gynecological ultrasound examination of each participant. Based solely on their independent examination, they will issue the final clinical report for each participant. The expert assessments will serve as one reference standard for evaluating scanning completeness, feature interpretation accuracy and diagnostic agreement. Histopathological findings, when available, or clinical follow-up for conservatively managed lesions will serve as the reference standard for evaluating diagnostic accuracy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female aged 18-75 years
  • With suspected ovarian masses identified clinically or by previous imaging examination
  • Eligible for and able to undergo transvaginal or transabdominal ultrasonography
  • Agree to provide written informed consent before enrollment

Exclusion criteria

  • No ovarian mass identified on ultrasound examination
  • Previous bilateral oophorectomy
  • Previous surgery or chemotherapy for ovarian cancer
  • Previous treatment for other malignant tumors
  • Presence of any psychiatric or psychological disorders that may prevent completion of the study procedures or follow-up
  • Concurrent participation in other clinical trials that may interfere with the outcomes of this study

Treatment and study plan

non-AI assisted and then AI assisted

Other

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.

AI assisted and then non-AI assisted

Other

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.

Primary outcomes

  1. Completeness of ultrasound feature acquisition

    Time frame: Up to 7 days from completion of the study

    The completeness of ultrasound feature acquisition will be assessed with reference to national authoritative quality-control standards. After each examination, all stored ultrasound images and videos will be labeled according to their intended purpose. A feature will be considered adequately acquired when at least one stored image or video provides sufficient visual evidence for assessment of that feature. The proportion of required features successfully acquired will be calculated. The proportion of redundant stored images will also be recorded as an additional indicator of acquisition quality.

  2. Accuracy of interpretation of individual ultrasound features

    Time frame: Up to 7 days from completion of the study

    The accuracy of interpretation of ultrasound features will be assessed by comparing the assessments made by junior sonographers under AI-assisted and unassisted conditions with the findings independently acquired and interpreted by expert sonographers during a separate repeat ultrasound examination. The accuracy rate for each feature will be calculated.

  3. Agreement between junior and expert sonographers in ultrasound diagnosis

    Time frame: Up to 7 days from completion of the study

    Agreement between junior and expert sonographers will be assessed for the final diagnosis of ovarian lesions. The assessments made by junior sonographers under AI-assisted and unassisted conditions will be compared with the corresponding diagnoses independently obtained by expert sonographers during a separate repeat ultrasound examination, which will then be quantified using appropriate agreement statistics.

  4. Diagnostic accuracy of ovarian tumors

    Time frame: Within 3 months after the ultrasonography examination

    Diagnostic accuracy will be assessed against histopathological diagnosis as the golden reference standard. This outcome will be evaluated only in participants who undergo surgical treatment and have definitive histopathological findings based on paraffin-embedded surgical specimens.

  5. Diagnostic performance of ovarian tumors

    Time frame: Within 3 months after the ultrasonography examination

    Area under curve will be assessed against histopathological diagnosis as the golden reference standard. This outcome will be evaluated only in participants who undergo surgical treatment and have definitive histopathological findings based on paraffin-embedded surgical specimens.

  6. Diagnostic performance of ovarian tumors

    Time frame: Within 3 months after the ultrasonography examination

    Diagnostic sensitivity and specificity will be assessed against histopathological diagnosis as the golden reference standard. This outcome will be evaluated only in participants who undergo surgical treatment and have definitive histopathological findings based on paraffin-embedded surgical specimens.

  7. Diagnostic performance of ovarian tumors

    Time frame: Within 3 months after the ultrasonography examination

    Diagnostic F1-score will be assessed against histopathological diagnosis as the golden reference standard. This outcome will be evaluated only in participants who undergo surgical treatment and have definitive histopathological findings based on paraffin-embedded surgical specimens.

Secondary outcomes

  1. Confidence in ultrasound feature acquisition and diagnosis

    Time frame: Up to 7 days from completion of the study

    Sonographers' confidence in the completeness and adequacy of feature acquisition and in their final diagnostic assessment will be evaluated using a predefined rating scale as follows: 5 = very confident, 4 = confident, 3 = uncertain, 2 = less confident, and 1 = not confident at al.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiale Qin, Prof., Professor

CONTACT

[email protected]

+86 0571-89998869

Ruixia Dai, Ph.D. student

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Collaborators

  • Shaoxing Maternity and Child Health Care Hospital

Registry information

Official study title

New Strategy of Knowledge-Enhanced Large Model for Ultrasound Scanning and Diagnosis of Ovarian Masses

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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