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Comparison of 3 Tesla MRI to 7 Tesla MRI for Evaluation of Prostate Suspicion Lesions

ConditionProstate Nodule
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-75
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Contraindications to MRI (e.g., non-compatible implants, pacemakers, severe claustrophobia)

diabetes mellitus

glucose intolerance

hyperglycemia

Trial design

Design model

Single group

Treatments tested in this trial

  • 3T and 7T MRI scans

    Diagnostic test

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: 3 Tesla (3T) versus 7 Tesla (7T) MRI in the assessment of suspicious prostate lesionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh) Status unavailable 70300, Zrifin, IsraelIsraelIsrael

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assaf-Harofeh Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: