Comparing 5.0T and 3.0T MRI for diagnosing prostate cancer
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
This study is testing whether a stronger 5.0T MRI can find prostate cancer more accurately than the standard 3.0T MRI in men who are being checked for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06612047 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the diagnostic efficacy of 5.0T and 3.0T biparametric magnetic resonance imaging (bpMRI) in diagnosing prostate cancer. It will evaluate the accuracy of both imaging techniques in determining the T stage of prostate cancer and assess the potential advantages of using 5.0T bpMRI over the more commonly used 3.0T bpMRI. Participants will undergo both imaging procedures, and their data will be collected prospectively to analyze the differences in diagnostic performance. The study seeks to address the limitations of current diagnostic methods and improve prostate cancer detection.
Who should consider this trial
Good fit: Ideal candidates include patients with indications for prostate biopsy who have not had prior prostate surgery and can undergo MRI without contraindications.
Not a fit: Patients with contraindications to MRI or those who do not require a prostate biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnosis, leading to better patient outcomes.
How similar studies have performed: While mpMRI has been widely studied, the specific comparison of 5.0T and 3.0T bpMRI for prostate cancer diagnosis is novel and has not been previously explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient has at least one indication for prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) ); 2. The primary prostate cancer has no other cancer history; 3. The 3.0TbpMRI examination was completed, and the images were clear and accessible; 4. The 5.0TbpMRI examination was further completed, and the images were clear and accessible; 5. The patient fully understands the relevant content of the study and voluntarily signs the informed consent. Exclusion Criteria: 1. The patient has contraindications to MRI examination, such as metal plates and heart stents in the body; 2. The patient does not have an indication for prostate biopsy or refuses biopsy; 3. The patient has contraindications to prostate biopsy; 4. 3.0T MRI considers that the patient has multiple lymph node or bone metastases; 5. The patient has undergone other prostatic surgery in the past; 6. The patient is unable to cooperate, has communication barriers, or refuses to sign the informed consent form.
Where this trial is running
Hefei, Anhui
- Department of Urology, The First Affiliated Hospital of USTC — Hefei, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Jun Xiao, M.D. — The First Affiliated Hospital of USTC
- Study coordinator: Changming Wang, M.D.
- Email: wcmurologist@mail.ustc.edu.cn
- Phone: 15840256553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.