Application of DWI in Diagnosis of Prostate Cancer

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04962269
• Collaborator: (none)
• Enrollment: 103
• Actual Duration (Months): 60.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Benign Prostatic Hyperplasia	Diagnostic Test: MRI

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 103 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Different Models of Multiple B-value DWI and Their Applications in Diagnosis of Prostate Cancer
• Actual Study Start Date: Jun 12, 2013
• Actual Primary Completion Date: Jun 21, 2018
• Actual Study Completion Date: Jun 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
prostate cancer The patient was pathologically diagnosed with prostate cancer	Diagnostic Test: MRI; monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model
benign prostatic hyperplasia The patient was pathologically diagnosed with benign prostatic hyperplasia

Outcome Measures

Primary Outcome Measures

1. pathological diagnosis [2013.10-2018.6]

   prostate cancer or benign prostatic hyperplasia

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

• Study Director: Jianyu Liu, Peking University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04962269
• Other Study ID Numbers: M2019176
• First Posted: Jul 14, 2021
• Last Update Posted: Jul 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: benign prostatic hyperplasia; Diffusion weighted imaging
• Additional relevant MeSH terms: Prostatic Neoplasms; Prostatic Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Jul 14, 2021