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

University of Lausanne Hospitals74 enrolled

Overview

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.

This study aims to compare the effectiveness of low-field MRI (0.55T) with traditional high-field MRI (3T) in prostate cancer screening and image quality improvement. The study is conducted in three phases: first, a pilot study with healthy volunteers to optimize the low-field MRI protocol; second, an evaluation of image quality between the two types of MRI in patients with metallic artifacts, particularly due to hip prostheses; and finally, the assessment of low-field MRI in patients with suspicious prostate lesions on high-field MRI (3T). The goal is to find an accessible solution for prostate cancer screening while maintaining or improving image quality.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).DEVICE

Performing low-field MRI to evaluate image quality with patients carrying metallic implants and assess the detection of suspicious prostate lesions.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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 suspicious lesion(s) * Individuals with a history of prostate cancer. * 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

Locations (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of as the reference standard.

Assess the overall quality of prostate MR images obtained with 0.55T compared to 3T MRI in patients with suspected prostate cancer, using metrics of SNR, CNR and the PI-QUAL scaling score. Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of a targeted prostate biopsy as the reference.

Time frame: 9 months

Secondary Outcomes

Protocol optimization on healthy volunteers

Assess image quality at 3T MRI and optimize the trade-off between quality and scan time.

Time frame: 1 month

Image quality on patients with metal implants

Compare 0.55T and 3T MRI image quality in patients with implants and suspected prostate cancer, assessing PI-QUAL scaling.

Time frame: 9 months

Central Contacts

Naïk Vietti-Violi, Dre

CONTACT

0795560240 Naik-Vietti-Violi@chuv.ch

Gorun Ilanjian, Dr

CONTACT

0795560232 Gorun.Ilanjian@chuv.ch

Data from ClinicalTrials.gov

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