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Multicenter Early Clinical Validation of an Artificial Intelligence Diagnostic Model Based on Bi-Parametric Magnetic Resonance Imaging for Prostate Cancer

Multicenter Early Clinical Validation of an Artificial Intelligence Diagnostic Model Based on Bi-Parametric Magnetic Resonance Imaging for Prostate Cancer

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092863
Enrollment
Unknown
Registered
2024-11-25
Start date
2024-02-20
Completion date
Unknown
Last updated
2024-12-02

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:The reference standard for patient grouping was radical prostatectomy, and patients who did not undergo radical prostatectomy were referred to the pathologic results of prostate biopsy,
Index test:The area under the receiver operating characteristic curve (AUC-ROC), accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: In the retrospective phase of the trial's initial stage, the inclusion criteria are as follows: Patients who had underwent prostate biopsy; patients who had undergone magnetic resonance multiparameter scanning and follow with operation of prostate biopsy. In the prospective phase of the trial's fourth stage, the inclusion criteria are as follows: All outpatients with suspected prostate cancer (Pca) who have not undergone any Pca-related treatments. In the second and third phases of the trial, data were randomly selected from the first phase with a roughly equal ratio of positive to negative cases, hence no separate inclusion/exclusion criteria were listed.

Exclusion criteria

Exclusion criteria: In the retrospective phase of the trial's initial stage, the exclusion criteria are as follows: 1. Patients who have undergone prostate biopsy within 6 weeks before the MRI scanning; 2. patients with prostate cancer chemotherapy, radiotherapy or other local treatments; 3. patients with multiple pelvic metastases of prostate cancer, with obvious destruction of local glands; 4. patients with pathologically confirmed malignant tumors of bladder, sarcoma, or other malignant tumors metastasized to the prostate; 5. patients with poor quality of the MR image caused by various artifacts, such as foreign objects, gases, and motions. In the prospective phase of the trial's fourth stage, the exclusion criteria are as follows: 1. Patients with suspected intracorporeal metallic foreign bodies or claustrophobia who refused MRI examinations; 2. Cases where post-scan image quality was suboptimal, hindering diagnostic accuracy.

Design outcomes

Primary

MeasureTime frame
The area under the receiver operating characteristic curve (AUC-ROC);negative predictive value (NPV);

Secondary

MeasureTime frame
accuracy;sensitivity;sensitivity;positive predictive value (PPV);

Countries

China

Contacts

Public ContactYun Bian

Shanghai Changhai Hospital

bianyun2012@foxmail.com+86 138 1635 7024

Outcome results

None listed

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