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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transvaginal Ultrasound diagnosis

radiologists interpretTransvaginal Ultrasound images without the help of Artificial Intelligence (AI) algorithm

Group Type NO_INTERVENTION

No interventions assigned to this group

AI enabled Transvaginal Ultrasound diagnosis

radiologists interpretTransvaginal Ultrasound images with the help of Artificial Intelligence algorithm

Group Type EXPERIMENTAL

Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm

Intervention Type DIAGNOSTIC_TEST

AI Enabled Transvaginal Ultrasound diagnosis for ovarian cancer

Interventions

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Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm

AI Enabled Transvaginal Ultrasound diagnosis for ovarian cancer

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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AI Enabled Transvaginal Ultrasound diagnosis

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No