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

T

Tongji Hospital

Status

Not yet enrolling

Conditions

Ovarian Cancer

Treatments

Diagnostic Test: Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm

Study type

Interventional

Funder types

Other

Identifiers

NCT04214782
2019-TJ-OVAB

Details and patient eligibility

About

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.

Enrollment

10,000 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10,000 participants in 2 patient groups

Transvaginal Ultrasound diagnosis
No Intervention group
Description:
radiologists interpretTransvaginal Ultrasound images without the help of Artificial Intelligence (AI) algorithm
AI enabled Transvaginal Ultrasound diagnosis
Experimental group
Description:
radiologists interpretTransvaginal Ultrasound images with the help of Artificial Intelligence algorithm
Treatment:
Diagnostic Test: Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm

Trial contacts and locations

0

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Central trial contact

Ding Ma, MD, PhD; Qinglei Gao, MD, PhD

Data sourced from clinicaltrials.gov

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