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Technical Validation and Clinical Translation of Time-dependent Diffusion MRI for Prostate Cancer Diagnosis

Technical Validation and Clinical Translation of Time-dependent Diffusion MRI for Prostate Cancer Diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122062
Enrollment
Unknown
Registered
2026-04-08
Start date
2026-04-12
Completion date
Unknown
Last updated
2026-04-14

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:1. Criteria for Gleason score: Gleason score was performed according to the 2019 International Society of Urological Pathology (ISUP) guidelines on biopsy or radical prostatectomy specim
Index test:1. MRI Cytometry Assessment Model for Prostate Cancer 2. Molecular Imaging Assessment Model for Prostate Cancer

Sponsors

First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Healthy Volunteers: 1. No prior history of prostate-related diseases or treatments; 2. Aged >= 18 years; 3. Signed informed consent prior to MRI examination. Patients with Suspected Prostate Tumor: 1. Underwent complete prostate conventional MRI, MR cytometry (TDD, IVIM, DKI, MD-MRI), and molecular metabolic imaging (APT, hyperpolarized MRI) due to clinical suspicion of prostate cancer; 2. Pathologically confirmed prostate cancer by biopsy within 3 months after MRI examination; 3. Underwent radical prostatectomy at our institution within 3 months after MRI examination.

Exclusion criteria

Exclusion criteria: Healthy Volunteers: 1. Unable to complete multiple MRI scans due to physical or psychological reasons; 2. MRI findings suggestive of prostate-related diseases (e.g., severe benign prostatic hyperplasia, prostatitis, etc.). Patients with Suspected Prostate Tumor: 1. Lesions not visible on MRI (PI-RADS < 3); 2. Prior history of prostate-related treatments.

Design outcomes

Primary

MeasureTime frame
Area under the receiver operating characteristic curve;Sensitivity;Specificity;

Secondary

MeasureTime frame
Accuracy;

Countries

China

Contacts

Public ContactWang Haiyi

First Medical Center of Chinese PLA General Hospital

wanghaiyi301@outlook.com+86 159 0126 1606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026