An interventional study of 3T and 7T MRI scans in Prostate Nodule, sponsored by Assaf-Harofeh Medical Center. Not yet recruiting at 1 site in Israel. Open to male participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Diagnostic
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.
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.
Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant serves as their own control, undergoing both 3T and 7T MRI scans.
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.
ROC analysis of diagnostic performance: 3T versus 7T MRI
ROC analysis (Receiver Operating Characteristic analysis) - A statistical method used to evaluate and compare diagnostic accuracy. It examines how well a test distinguishes between diseased and non-diseased cases across different thresholds.
Time frame: Assessed at the time of MRI acquisition during the study imaging visit.
Sensitivity and Specificity of diagnostic performance: 3T versus 7T MRI
Sensitivity - The ability of the MRI to correctly identify patients who truly have disease (true positive rate). High sensitivity means fewer missed cases. Specificity - The ability of the MRI to correctly identify patients who do not have disease (true negative rate). High specificity means fewer false alarms or false positives.
Time frame: Assessed at the time of MRI acquisition during the study imaging visit.
Lesion conspicuity of diagnostic performance: 3T versus 7T MRI
How clearly and visibly an abnormal lesion can be seen on MRI images compared with surrounding tissue. Higher conspicuity generally makes lesions easier to detect and characterize.
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
a standardized scoring system used in prostate MRI to estimate the likelihood of clinically significant prostate cancer. Scores range from 1 (very low likelihood) to 5 (very high likelihood).
Time frame: Assessed at the time of MRI acquisition during the study imaging visit.
Quantitative imaging metrics of diagnostic performance: 3T versus 7T MRI
Numerical measurements derived from MRI images, such as lesion size, signal intensity, contrast ratios, diffusion values (e.g., ADC), or texture features, used to objectively compare imaging performance.
Time frame: Assessed at the time of MRI acquisition during the study imaging visit.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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