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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04214782
• Other study ID #: 2019-TJ-OVAB
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2021
• Source: Tongji Hospital
• Contact: Qinglei Gao, MD, PhD
• Phone: 13871127473
• Email: qingleigao[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm
AI Enabled Transvaginal Ultrasound diagnosis for ovarian cancer

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Tongji Hospital	First Affiliated Hospital, Sun Yat-Sen University, Henan Cancer Hospital, Hubei Cancer Hospital, Qilu Hospital of Shandong University, The First People's Hospital of Jingzhou, Xiangyang Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy	diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer	2 years
Secondary	time cost for Transvaginal Ultrasound image interpretation	time cost for radiologists to interpret Transvaginal Ultrasound images	2 years