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Recruiting NCT07552285

The Enhancement of Diagnostic and Grading Efficacy of Prostate Cancer by New MRI Sequences: A Prospective Observational Study Based on New MRI Sequences in a Single Center

— Observational Prostate Cancer Prostate Cancer (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational study.
Who it may be relevant to
Registry conditions: Prostate Cancer, Prostate Cancer (Diagnosis). Basic parameters: 20 years — 90 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this clinical trial aims to explore the diagnostic efficacy and grading of prostate cancer by a novel MRI sequences such as MAGiC，OGSE,CEST,IVIM,etc.The main question it aims to answer is: Can the novel non-contrast multiparametric MRI imaging improve the accuracy of diagnosis and grading of prostate cancer? For patients with clinical suspicion of prostate cancer, both conventional and new sequences magnetic resonance scans are conducted, with surgical or biopsy pathological results serving as the gold standard.

Interventions

  • Other observational study
    The researchers will conduct observations, collect data and conduct follow-ups on the participants, but will not actively alter their treatment or health conditions.

Primary outcome measures

  • Microstructure parameters related to the OGSE sequence [Time frame: Within one week after the MRI scan]
  • CEST sequence-related numerical values [Time frame: Within one week after the MRI scan]
  • MAGIC sequence-related numerical values [Time frame: Within one week after the MRI scan]
  • IVIM sequence-related numerical values [Time frame: Within one week after the MRI scan]
Secondary outcome measures (1)
  • Regular sequence-related numerical values [Time frame: Within one week after the MRI scan]

Eligibility criteria

Inclusion criteria

  • Patients with a high clinical suspicion of prostate cancer and elevated tPSA levels;
  • Patients with no prior history of other tumors;
  • Patients with no contraindications to MRI, including claustrophobia, presence of pacemakers, cardiac stents, or metal implants such as screws and plates.

Exclusion criteria

  • The patient has a history of malignant tumors and has received corresponding treatment;
  • Prior to the MRI examination, the patient has undergone treatment for prostate cancer, including endocrine therapy, radiotherapy, etc.;
  • Patients who have previously undergone radical prostatectomy for prostate cancer.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07552285 · 2025465

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗