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Can ovarian cancer detection be improved using AI-driven diagnostic support applied to ultrasound images?

Diagnostic accuracy of computerized ultrasound image analysis using deep neural network models as compared to subjective assessment using pattern recognition or IOTA-ADNEX model - a prospective multi-centre trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN88222986
Enrollment
700
Registered
2023-04-01
Start date
2021-03-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Ovarian cancer Cancer

Interventions

Current interventions as of 28/05/2024: A prospective study including >700 patients with ovarian tumors, assessed by examiners with varying expertise (at least 400 assessments by non-experts, and 300

Sponsors

Karolinska Institute
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged =15 years 2. Newly detected ovarian tumor 3. Capable of understanding the study information and accepts participation

Exclusion criteria

Exclusion criteria: 1. Aged <15 years 2. Patients who are not capable of understanding the study information or don't accept participation

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy in differentiating benign from malignant ovarian tumors measured by comparing the outcomes from subjective assessment, IOTA-ADNEX model scoring and previously developed deep neural network (DNN) models at one timepoint

Secondary

MeasureTime frame
Accuracy in differentiating benign from malignant ovarian tumors measured by comparing the outcomes from subjective assessment, IOTA-ADNEX model scoring and previously developed DNN models - stratified by user experience (expert examiners versus non-expert examiners) at one timepoint

Countries

Czech Republic, Italy, Lithuania, Philippines, Poland, Spain, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026