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The clinical validation of diagnostic efficacy of AI in prostate cancer based on mpMRI

The clinical validation of diagnostic efficacy of AI in prostate cancer based on mpMRI

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100054653
Enrollment
Unknown
Registered
2021-12-23
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-11-28

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
diagnosis&#32

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. For the purpose of qualitative diagnosis, the images of those who have the indications for mpMRI prostate imaging examination and undergo MR examination according to their own clinical needs; 2. No treatment before mpMRI examination, including endocrine therapy, radiation therapy, etc.; 3. The image data of prostate mpMRI examination are complete (including T2WI, DWI and DCE) and the image quality is satisfactory for diagnosis; 4. Comprehensive clinical diagnosis results can be obtained from the medical record system, such as: ultrasound-guided transrectal biopsy (TRUS-BP) or postoperative pathological results of radical prostatectomy (RP). Laboratory test results, etc.

Exclusion criteria

Exclusion criteria: Negative needle biopsy cases with a follow-up time of less than 1 year or the possibility of clinically significant prostate cancer (eg, prostate-specific antigen, digital rectal examination, progression of MR findings) during follow-up.

Design outcomes

Primary

MeasureTime frame
Detection sensitivity of prostate cancer (based on per lesion);Detection sensitivity of prostate cancer (based on per patient);Detection specificity of prostate cancer (based on per patient);

Secondary

MeasureTime frame
Detection sensitivity of software for prostate cancer (based on per lesion);Sensitivity and specificity of software for prostate cancer detection (based on per patient);Analysis of trial reading time;Assessmentof the diagnostic confidence of radiologist ;Evaluation of software stability and satisfaction ;

Countries

China

Contacts

Public ContactWang Xiaoying

Peking University First Hospital

Wang_xiaoying@bjmu.edyu.cn+86 13511077396

Outcome results

None listed

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