Application of DWI in Diagnosis of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Different Models of Multiple B-value DWI and Their Applications in Diagnosis of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04962269
• Other study ID #: M2019176
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostate Cancer
• Prostatic Hyperplasia
• Prostatic Neoplasms

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