Skip to content

Retrospective, multi-center, multi-reader, multi-case (MRMC) clinical trial to evaluate the effectiveness and safety of MRI assisted prostate cancer diagnostic software

Clinical trials of MRI assisted prostate cancer diagnostic software

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079925
Enrollment
Unknown
Registered
2024-01-16
Start date
2024-01-31
Completion date
Unknown
Last updated
2024-01-22

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:Senior radilogists delineate prostate cancer lesions on the T2-weighted sequence of the MR images based on the pathology report description. The delineation results undergo review by ano
Index test:Doctors read MR image without AI assisted
Doctors read MR image in AI software assisted conditions.

Sponsors

The First People's Hospital of Changzhou
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Positive Case Inclusion Criteria: 1. Male patients aged =18 years old; 2. Completed prostate or abdominal pelvic MRI examination, including T2W non-fat-suppressed cross-sectional sequence, DWI sequence, ADC sequence; 3. Image slice thickness =1mm, =7mm; 4. Highest b value in DWI sequence =600 s/mm2; 5. Pathologically confirmed positive cases (interval between pathological examination and MR examination =1 month). Negative Case Inclusion Criteria: 1. Male patients aged =18 years old; 2. Completed prostate or abdominal pelvic MRI examination, including T2W non-fat-suppressed cross-sectional sequence, DWI sequence, ADC sequence; 3. Image slice thickness =1mm, =7mm; 4. Highest b value in DWI sequence =600 s/mm2; 5. Pathologically confirmed negative cases (interval between pathological examination and MR examination =1 month) or negative cases confirmed through at least one year of clinical follow-up examinations.

Exclusion criteria

Exclusion criteria: 1. Incomplete imaging scan coverage; 2. Poor MR image quality affecting interpretation (such as significant artifacts, excessive image noise, etc.); 3. History of prior prostate biopsy, surgery, radiotherapy, or medication treatment; 4. Inadequate ADC sequence; 5. Pathologically confirmed positive lesions that are difficult to recognize on the MR images; 6. Cases deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;AFROC-AUC;

Countries

China

Contacts

Public ContactWei Xing

The First People's Hospital of Changzhou

suzhxingwei@126.com+86 139 6123 6568

Outcome results

None listed

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