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NCT07249281Recruiting

MR Microstructural Imaging for Prostate Cancer Diagnosis

Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms

Source: ClinicalTrials.gov · Last updated 25 Nov 2025

Brief summary (registry, in English)

The goal of this multi-center clinical study is to evaluate whether time-dependent diffusion MRI (TDDMRI) can provide reliable microstructural imaging markers for the diagnosis of prostate cancer. The main questions this study aims to answer are: * Do TDDMRI-derived microstructural parameters (such as cell size and density) improve diagnostic accuracy for prostate cancer compared with conventional MRI? * How well do the microstructural parameters correlate with whole-slide pathology findings? * Can the investigators determine diagnostic models combining multiple features for presurgical diagnosis across multiple centers? Participants with suspected prostate cancer will undergo 3T MRI including TDDMRI. Microstructural parameters will be quantified and compared with standard multiparametric MRI. All participants will also receive prostate biopsy or prostatectomy, and imaging findings will be validated against histopathology. This study will: * Collect TDDMRI and conventional MRI data from six hospitals. * Derive and validate imaging markers of prostate cancer based on microstructural parameters. * Compare diagnostic performance across centers and against pathology as the reference standard.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2000 (estimated)
First submitted
1 Sept 2025
Start date
1 Sept 2020
Primary completion date
31 Dec 2028
Lead sponsor
First Affiliated Hospital of Zhejiang University
NCT number
NCT07249281

What you commit to

  • Study type: Observational
  • Planned participants: 2000
  • From 1 Sept 2020 to the primary completion date, 31 Dec 2028
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to MRI (e.g., pacemaker, ferromagnetic implants, severe claustrophobia).
  • Prior treatment for prostate cancer (surgery, radiation, hormonal therapy, chemotherapy).

Other illness

  • Severe comorbid conditions precluding MRI or biopsy.

Other

  • Inability to provide informed consent.
  • Poor image quality due to motion or technical artifacts (assessed at imaging QC).

Who the study is looking for

  • Clinical suspicion of prostate cancer (elevated PSA, abnormal digital rectal examination, or other clinical indication).
  • Undergoing prostate MRI including TDDMRI as part of diagnostic evaluation. Able and willing to provide written informed consent.

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The First Affiliated Hospital of Dalian Medical University
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DalianChinaRecruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Zhejiang Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaCompleted

This page is information, not medical advice. Discuss any trial with your doctor.