Application of DWI in Diagnosis of Prostate Cancer

July 4, 2021 updated by: Peking University Third Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

patients with prostatic diseases confirmed as prostate cancer or benign prostatic hyperplasia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological diagnosis
Time Frame: 2013.10-2018.6
prostate cancer or benign prostatic hyperplasia
2013.10-2018.6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Director: Jianyu Liu, Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2013

Primary Completion (Actual)

June 21, 2018

Study Completion (Actual)

June 21, 2018

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2019176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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