NCT06636747

Brief Summary

hrDWI might be an alternative to cDWI for the prostate imaging.

  1. 1.increase the signal-to-noise ratio and contrast-to-noise ratio, yielding high-fidelity images with less noise in general
  2. 2.improve the diagnostic accuracy of PCa in particular than conventional DWI

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress92%
Aug 2023Jul 2026

Study Start

First participant enrolled

August 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 8, 2024

Last Update Submit

October 8, 2024

Conditions

Prostate CancerProstate Disease

Keywords

diffusion weighted imagingprostate cancer

Outcome Measures

Primary Outcomes (1)

  • image quality evaluation

    objective and subjective image quality and lesion conspicuity

    2024.01-2025.12

Secondary Outcomes (1)

  • prostate cancer diagnosis

    2024.01-2025.12

Eligibility Criteria

Age55 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men larger than 55 years old were eligible to participate if they had a clinical suspicion of PCa with no previous biopsy. This included those with elevated PSA (\> 4 ng/ml), or with suspicious digital rectal examination findings, or with suspicious findings on ultrasound examination, or with a family history of PCa.

You may qualify if:

  • Patients who underwent standard MR scanning including T2WI, cDWI , hrDWI and respective calculated apparent diffusion coefficient (ADC) maps;
  • Complete clinical information.

You may not qualify if:

  • Men were excluded if they were using 5-alpha-reductase inhibitors at time of examination or has used such during the previous six months; or if they had a previous history of prostatic biopsy, prostatic surgery, or treatment for PCa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Yu-Dong Zhang

Nanjing, 210029, China

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fei-Yun Wu

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Dong Zhang

CONTACT

86-18251966069njmu_zyd@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

August 1, 2023

Primary Completion

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

CN(2)