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Recruiting NCT06482489

Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)

Trial Parameters

Condition Prostate Cancer
Sponsor University of Lausanne Hospitals
Study Type OBSERVATIONAL
Phase N/A
Enrollment 74
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2024-11-01
Completion 2025-05-31
Interventions
Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Brief Summary

This study compares the effectiveness of low-field MRI (0.55T) with high-field MRI (3T) in prostate cancer screening and image quality. It consists of three phases: optimizing the low-field MRI protocol with healthy volunteers, evaluating image quality in patients with metallic artifacts (like hip prostheses), and assessing low-field MRI in patients with suspicious prostate lesions found on high-field MRI.

Eligibility Criteria

Inclusion Criteria: Work Package1 (WP): 0.55T MRI Protocol Development * Healthy male volunteers aged 18 and above. * Agree to be contacted for incidental findings * Signed informed consent WP2: 0.55T Prostate MRI with patients with metallic implant(s) * Adult men (≥18 y.o) with 3T MRI reported as sub-diagnostic due to metallic implants * Signed informed Consent WP3: 0.55T Prostate MRI with patients with suspicious lesion(s) * Adult men (≥18 y.o) * PI-RADS 4/5 lesions detected on 3T MRI, schedules for targeted biopsy * Signed informed consent Exclusion Criteria: WP1: 0.55T MRI Protocol Development * Individuals with a history of prostate cancer * MR Contraindications as listed in the MR Safety Screening form WP2: 0.55T Prostate MRI with patients with metallic implant(s) * Contraindications as per MD instructions * Any condition making the patient unsuitable for the study * Refusal to be notified in case of incidental finding on the examination WP3: 0.55T Prostate MRI with patients with

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