NCT07603908

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jan 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 22, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

April 16, 2026

Last Update Submit

May 17, 2026

Conditions

Prostate Nodule

Keywords

3T MRI7T MRI

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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).

    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.

    Assessed at the time of MRI acquisition during the study imaging visit.

Study Arms (1)

3 Tesla (3T) versus 7 Tesla (7T) MRI in the assessment of suspicious prostate lesions

EXPERIMENTAL

Each participant serves as their own control, undergoing both 3T and 7T MRI scans.

Diagnostic Test: 3T and 7T MRI scans

Interventions

3T and 7T MRI scansDIAGNOSTIC_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.

3 Tesla (3T) versus 7 Tesla (7T) MRI in the assessment of suspicious prostate lesions

Eligibility Criteria

Age18 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, Israel, 70300, Israel

Location

Study Officials

  • Shai Efrati

    Asaf-Harofhe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai Efrati, MD

CONTACT

972549212866efratishai@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

May 22, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

May 22, 2026

Record last verified: 2026-02

Locations

IL(1)