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

Study Overview
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Diagnostic Test: Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Transvaginal Ultrasound diagnosis<br>radiologists interpretTransvaginal Ultrasound images without the help of Artificial Intelligence (AI) algorithm | |
| Experimental: AI enabled Transvaginal Ultrasound diagnosis<br>radiologists interpretTransvaginal Ultrasound images with the help of Artificial Intelligence algorithm | Diagnostic Test: Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm<br>* AI Enabled Transvaginal Ultrasound diagnosis for ovarian cancer<br>* Other names: AI Enabled Transvaginal Ultrasound diagnosis;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time cost for Transvaginal Ultrasound image interpretation | time cost for radiologists to interpret Transvaginal Ultrasound images | 2 years |