NCT04962269

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 29, 2021

Last Update Submit

July 4, 2021

Conditions

Prostate CancerBenign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasiaDiffusion weighted imaging

Outcome Measures

Primary Outcomes (1)

  • pathological diagnosis

    prostate cancer or benign prostatic hyperplasia

    2013.10-2018.6

Study Arms (2)

prostate cancer

The patient was pathologically diagnosed with prostate cancer

Diagnostic Test: MRI

benign prostatic hyperplasia

The patient was pathologically diagnosed with benign prostatic hyperplasia

Interventions

MRIDIAGNOSTIC_TEST

monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model

prostate cancer

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • The exam including T1WI、T2WI and multiple b-value DWI.
  • Comfired by pathology as prostate cancer or benign prostatic hyperplasia in one month after the MRI exam.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jianyu Liu

    Peking University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 14, 2021

Study Start

June 12, 2013

Primary Completion

June 21, 2018

Study Completion

June 21, 2018

Last Updated

July 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share