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Research and Application of Ultrasonic Intelligent Diagnosis System for Ovarian Mass

Research on Automatic Detection of Ovarian Mass and Intelligent Auxiliary Diagnosis System Based on Multimodal Ultrasound Images

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06528236
Enrollment
100000
Registered
2024-07-30
Start date
2024-07-30
Completion date
2029-07-30
Last updated
2024-07-30

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

Conditions

Adnexal Mass, Ovarian Neoplasms

Brief summary

Research on automatic detection of ovarian mass and intelligent auxiliary diagnosis system based on multimodal ultrasound images.

Detailed description

Investigators aimed to develop an ultrasonic intelligent diagnosis system for ovarian mass based on multimodal ultrasound images.

Interventions

Using the artificial intelligence model to diagnosis benign, borderline, and malignant ovarian masses.

Sponsors

The Second Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
Sichuan provincial maternity and child health care hospital
CollaboratorUNKNOWN
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
Aksu First People's Hospital
CollaboratorUNKNOWN
Women's Hospital School Of Medicine Zhejiang University
CollaboratorOTHER
Zhejiang Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

1. During gynecological ultrasound examination, at least one patient with persistent ovarian tumor was found. 2. The patient underwent surgical treatment and the histopathological results.

Exclusion criteria

1. Histopathological analysis confirms non-ovarian tumor; 2. Histopathological results are inconclusive; 3. Issues with image quality: the ovarian mass is incomplete and does not show some surrounding tissues (but the mass is too large to exclude completely); the images are overly blurry, making it difficult to determine the characteristics of the ovarian mass (possible reasons include hardware quality issues with the ultrasound machine, motion blur, focusing problems, presence of intestinal gas in the patient); gain settings make it difficult to judge the characteristics of the ovarian mass (such as low contrast, excessively dark images, or saturation); the presence of artifacts affects the assessment of ultrasound characteristics of the ovarian mass and should be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Area under the curveThrough study completion, an average of 1 yearAUC (Area Under the Curve) is a common index used to evaluate the performance of binary classification model.

Secondary

MeasureTime frameDescription
SensitivityThrough study completion, an average of 1 yearSensitivity refers to the ability of the test to correctly identify a positive result in an individual who actually has the disease. It represents the proportion of cases in which the test is able to detect a positive for the disease

Other

MeasureTime frameDescription
SpecificityThrough study completion, an average of 1 yearSpecificity refers to the ability of the test to correctly identify a negative result in an individual who does not actually have the disease. It represents the proportion of cases where the disease is negative that the test is able to detect.
AccuracyThrough study completion, an average of 1 yearAccuracy refers to the degree to which the results of the diagnostic test are consistent with the actual situation
Positive predicative valueThrough study completion, an average of 1 yearPositive Predictive Value indicates the probability that a test result will be true if it is positive. In other words, it represents the proportion of individuals who are diagnosed as positive when the test result is positive who actually have the disease
Negative predictive valueThrough study completion, an average of 1 yearNegative Predictive Value refers to the probability that if a test result is negative, the result will be true negative. It represents the proportion of individuals who are diagnosed as negative when the test results are negative that are truly free of the disease

Contacts

Primary ContactYingnan Wu, Doctor
litaosun1971@sina.com0086 19883106164

Outcome results

None listed

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