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A multicenter, prospective, randomized clinical trial of artificial intelligence fusion of Venus ultrasound MR-TRUS images in prostate biopsy

A multicenter, prospective, randomized clinical trial of artificial intelligence fusion of Venus ultrasound MR-TRUS images in prostate biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094902
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Prostate Cancer

Interventions

Gold Standard:Pathological results, Gleason Grading
Index test:To explore the method of prostate biopsy guided by cross-modal artificial intelligence image elastic registration and fusion based on prostate multi-parametric magnetic resonance imaging an

Sponsors

Renmin Hospital of Wuhan University Hubei General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male, under the age of 80; 2. Meet any of the following criteria: (1) Digital rectal examination (DRE) revealed suspicious nodules in the prostate, with any PSA values; (2) PSA >= 10 µg/L; (3) 4 µg/L = 3; 4. Good compliance, able to communicate well with researchers; 5. Volunteer to participate in the research and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Confirmed prostate cancer or acute prostatitis patients; 2. During the acute infection period, or clinical significance urinary tract infections; 3. Prostate biopsy performed within one month; 4. In the period of decompensation due to cardiac insufficiency; 5. Individuals with severe bleeding tendencies, or those who are unable to stop taking anticoagulants for a long time; 6. Severe internal hemorrhoids, external hemorrhoids, perianal or rectal lesions; 7. Patients with severe bone and joint diseases who cannot undergo lithotomy; 8. Having a hypertensive crisis; 9. Individuals who are unable to undergo anesthesia; 10. Those who suffer from mental illness or mental disorders and are unable to understand the informed consent form; 11. People who use electronic instruments such as built-in pacemakers, cochlear implants, and nerve stimulators; 12. Other contraindications to surgery, or those deemed unsuitable by the researcher to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Detection rate of cs-PCa;

Secondary

MeasureTime frame
Detection rate of any-PCa;Registration and fusion completion time (from magnetic resonance data import to MR-TRUS image fusion completion);Biopsy completion time (the time from the first needle to the last needle completed);Visual Analogue Scale;

Countries

China

Contacts

Public ContactFan Cheng

Renmin Hospital of Wuhan University Hubei General Hospital

646064793@qq.com+86 27 8804 1911

Outcome results

None listed

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