Actively Recruiting
Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer: A Prospective, Single Center and Paired-design Diagnostic Study
Led by Anhui Provincial Hospital · Updated on 2025-02-11
150
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic differences between 5.0T and 3.0T biparametric magnetic resonance imaging (bpMRI) for prostate cancer detection in this prospective observational study. The study aims to compare the effectiveness of these two imaging methods in diagnosing prostate cancer and assessing tumor stage, addressing limitations of current diagnostic tools like mpMRI and prostate biopsy. This research is conducted by Anhui Provincial Hospital to explore whether the newer 5.0TbpMRI can improve specificity and tumor staging accuracy compared to 3.0TbpMRI. Participants suspected of prostate cancer will undergo both 5.0TbpMRI and 3.0TbpMRI scans within one month. The MRI sequences include T1-weighted imaging, multi-plane T2-weighted imaging, and multi-b-value diffusion-weighted imaging. All participants will also receive a transperineal prostate biopsy, including systematic and targeted sampling, to provide pathological diagnosis results for comparison. During the study, researchers will collect and analyze imaging data and biopsy results to compare the diagnostic accuracy and reliability of the two MRI methods. The primary outcome measures include the diagnostic efficacy of 5.0TbpMRI versus 3.0TbpMRI and their accuracy in tumor staging. The study involves data collection over approximately one to two months, with participants providing informed consent and undergoing imaging and biopsy procedures as part of their involvement.
CONDITIONS
Brief Title
Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has at least one indication for prostate biopsy according to Chinese expert consensus (2022 edition)
- The patient has no history of other cancers besides primary prostate cancer
- The 3.0TbpMRI examination is completed with clear and accessible images
- The 5.0TbpMRI examination is completed with clear and accessible images
- The patient understands the study and voluntarily signs informed consent
You will not qualify if you...
- The patient has contraindications to MRI, such as metal implants or heart stents
- The patient has no indication for prostate biopsy or refuses biopsy
- The patient has contraindications to prostate biopsy
- The 3.0T MRI shows multiple lymph node or bone metastases
- The patient has undergone prior prostate surgery
- The patient is unable to cooperate, has communication barriers, or refuses informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 1 month
Participants undergo 5.0T and 3.0T biparametric magnetic resonance imaging (bpMRI) to evaluate prostate cancer.
2 imaging visits (5.0T and 3.0T bpMRI) within one month
Duration - Within 1 month
Participants undergo transperineal prostate biopsy (systematic and targeted) to obtain pathological diagnosis results.
1 biopsy visit (transperineal prostate biopsy)
Trial Site Locations
Total: 1 location
1
Department of Urology, The First Affiliated Hospital of USTC
Hefei, Anhui, China, 230001
Actively Recruiting
Research Team
C
Changming Wang, M.D.
J
Jun Xiao, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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