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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04962269
Other study ID # M2019176
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 12, 2013
Est. completion date June 21, 2018

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study compared the performance of different models of multiple b-value DWI in diagnosing prostate cancer.


Description:

Diffusion weighted imaging (DWI) plays an important role in the diagnosis and stratification of prostate cancer. Traditional DWI apply the apparent diffusion coefficient (ADC) to reflect the diffusion of tissue water, which is a parameter calculated by a monoexponential model with 2b values. In recent years, the development of multiple b-value DWI facilitates the appearance of many new mathematical models. Different models have different features, but their value of applications in prostate cancer still need to be confirmed. This study was aiming to: (1) compare the parameters derived from monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model between prostate cancer and benign prostatic hyperplasia; (2) compare the difference of these parameters between low-grade (Gleason score ≤ 3+4) and high-grade (Gleason score ≥ 4+3) cancer; (3) find whether these parameters derived from new models are superior to ADC derived from traditional monoexponetial model.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date June 21, 2018
Est. primary completion date June 21, 2018
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: 1. The exam including T1WI?T2WI and multiple b-value DWI. 2. Comfired by pathology as prostate cancer or benign prostatic hyperplasia in one month after the MRI exam. Exclusion Criteria: - 1.No Gleason score data. 2.Awful quality of imagings or artifacts affectting diagnosis. 3.No lesion larger than 0.5cm. 4.Any surgery or treatment before MRI exam. 5.Biopsy in 4 weeks before MRI exam.

Study Design


Intervention

Diagnostic Test:
MRI
monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary pathological diagnosis prostate cancer or benign prostatic hyperplasia 2013.10-2018.6
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