Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm

Not Applicable

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Diagnostic Test: Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm

• Registration Number: NCT04214782
• Lead Sponsor: Tongji Hospital

Brief Summary

Ovarian cancer is relatively rare but fatal with an annual incidence rate of 11.8 per 100 000 and a high mortality-to-incidence ratio of \>0.6. The modest diagnostic accuracy of TVU has risen some concerns about the over-treatment.Now, with the development of artificial intelligence (AI), we may have a better chance to interpret TVU imagines with high efficiency, reproducibility and accuracy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-28
• Study First Submitted QC: 2019-12-28
• Study First Posted: 2020-01-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07
• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

• Women scheduled for Transvaginal Ultrasound examination for adnexal lesions;
• Women aged over 18 years old;
• Women willing to participant in this study evidenced by signing the informed consent.

Exclusion Criteria

• Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa;
• Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination;
• Women with mental abnormal;
• Women did not cooperate or participate in other clinical trials;
• Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI enabled Transvaginal Ultrasound diagnosis	Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm	radiologists interpretTransvaginal Ultrasound images with the help of Artificial Intelligence algorithm

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy	2 years	diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer

Secondary Outcome Measures

Name	Time	Method
time cost for Transvaginal Ultrasound image interpretation	2 years	time cost for radiologists to interpret Transvaginal Ultrasound images