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Clinical Trials/NCT04214782
NCT04214782
Not yet recruiting
Not Applicable

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

Tongji Hospital0 sites10,000 target enrollmentOctober 1, 2022
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Tongji Hospital
Enrollment
10000
Primary Endpoint
diagnostic accuracy
Status
Not yet recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
October 1, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Qinglei Gao

Clinical Professor

Tongji Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

diagnostic accuracy

Time Frame: 2 years

diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer

Secondary Outcomes

  • time cost for Transvaginal Ultrasound image interpretation(2 years)

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