Clinical trial · Observational
Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are: * Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer. * Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer. The data of participants was collected prospectively.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI
- description
- All enrolled patients need to undergo 5.0TbpMRI and 3.0TbpMRI (within one month). The magnetic resonance imaging sequences mainly include T1WI, multi-plane T2WI and multi-b-value DWI images.
- interventionNames
- Procedure: Prostate biopsy
Primary outcomes (1)
- measure
- Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.
- timeFrame
- through study completion, an average of 1 month
- description
- Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value.
Secondary outcomes (2)
- measure
- Evaluation of the reliability (repeatability) of the diagnostic test.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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