Comparison of 3 Tesla MRI to 7 Tesla MRI for Evaluation of Prostate Suspicion Lesions
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: 3T and 7T MRI scans.
- Who it may be relevant to
- Registry conditions: Prostate Nodule. Basic parameters: 18 years — 75 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
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A comparison of 3 Tesla MRI to 7 Tesla MRI for Evaluation of Prostate Suspicious Lesions. Assess the added diagnostic value of ultra-high-field (7T) MRI over the current clinical standard (3T MRI) in detecting and characterizing suspicious prostate lesions. Evaluate whether dynamic deuterated glucose-enhanced imaging at 7T can offer improved contrast without the use of gadolinium-based agents.
Detailed description
Multiparametric MRI (mpMRI) at 3 Tesla is the current standard of care for the evaluation of prostate cancer, but its diagnostic accuracy is limited by false positives, particularly in the transition zone. This leads to unnecessary biopsies and potential overtreatment. Ultra-high-field 7 Tesla (7T) MRI offers higher signal-to-noise ratio, superior spatial and spectral resolution, and the ability to implement advanced imaging techniques without the need for endorectal coils. In addition, dynamic glucose-enhanced MRI at 7T provides a promising alternative to gadolinium-based contrast agents, which are associated with safety concerns.
Interventions
- Diagnostic test 3T and 7T MRI scans
Imaging protocols will include multiparametric sequences at both field strengths, with the addition of high-resolution anatomical and optional dynamic glucose-enhanced imaging at 7T.
Primary outcome measures
- ROC analysis of diagnostic performance: 3T versus 7T MRI [Time frame: Assessed at the time of MRI acquisition during the study imaging visit.]
- Sensitivity and Specificity of diagnostic performance: 3T versus 7T MRI [Time frame: Assessed at the time of MRI acquisition during the study imaging visit.]
- Lesion conspicuity of diagnostic performance: 3T versus 7T MRI [Time frame: Assessed at the time of MRI acquisition during the study imaging visit.]
- PI-RADS classification - The Prostate Imaging Reporting and Data System: 3T versus 7T MRI [Time frame: Assessed at the time of MRI acquisition during the study imaging visit.]
- Quantitative imaging metrics of diagnostic performance: 3T versus 7T MRI [Time frame: Assessed at the time of MRI acquisition during the study imaging visit.]
Eligibility criteria
Inclusion criteria
- male patients referred for clinical 3T prostate MRI at Shamir Medical Center
- male patients who consent to undergo an additional 7T scan at the Weizmann Institute.
Exclusion criteria
- Contraindications to MRI (e.g., non-compatible implants, pacemakers, severe claustrophobia)
- diabetes mellitus
- glucose intolerance
- hyperglycemia
- hyperlactatemia
- chronic kidney disease (GFR <45 mL/min/1.73 m2).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Israel · 1 center
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh — Zrifin
Identifiers
NCT: NCT07603908 · 0230-25-ASF