prostate cancer
Conditions
Interventions
Gold Standard:This clinical trial uses the target puncture area results ultimately outlined by the expert panel as the gold standard.
Index test:Prostate biopsy surgery planning software,
using a crossover self-controlled design, the same reader reviews the images of the same subject with and without the experimental device (AI sof
Sponsors
The First Medical Center of Chinese PLA general hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male, age between 18 and 85 years old; 2. Suspicious lesions detected on multiparametric prostate MRI; 3. Prostate MRI images include T2WI, DWI, and ADC sequences; 4. Image slice thickness <=5mm; 5. Complete prostate biopsy pathology reports, prostate MRI DICOM data, and prostate MRI reports available; 6. Prostate biopsy completed at this hospital; 7. Oral/telephone informed consent obtained, or informed consent waived with ethics committee approval.
Exclusion criteria
Exclusion criteria: 1. Poor image quality or non-standard scanning that affects interpretation and planning, such as incomplete images, obvious respiratory motion artifacts, or low resolution; 2. Those who have previously undergone prostate surgery or radiotherapy; 3. Those with a history of other pelvic malignant tumors; 4. Those whom the researchers believe are otherwise unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity of AI in identifying suspicious lesions;Recognition sensitivity; | — |
Secondary
| Measure | Time frame |
|---|---|
| The accuracy of AI in identifying suspicious lesions;Time;performance; | — |
Countries
China
Contacts
Public ContactZhang Xu
Chinese PLA general hospital
Outcome results
None listed