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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04214782

Enrollment

10000

Registered

2020-01-02

Start date

2022-10-01

Completion date

2024-10-01

Last updated

2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

DIAGNOSTIC_TESTArtificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm

AI Enabled Transvaginal Ultrasound diagnosis for ovarian cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
diagnostic accuracy	2 years	diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer

Secondary

Measure	Time frame	Description
time cost for Transvaginal Ultrasound image interpretation	2 years	time cost for radiologists to interpret Transvaginal Ultrasound images

Contacts

Primary ContactQinglei Gao, MD, PhD

qingleigao@hotmail.com13871127473

Backup ContactDing Ma, MD, PhD

dingma424@126.com13886090620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026