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

Not Applicable

Not yet recruiting

• Conditions: Ovarian Cancer

• 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

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