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

Last updated: March 31, 2025
Sponsor: University of Lausanne Hospitals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer

Treatment

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

Clinical Study ID

NCT06482489
2024-D0049
  • Ages > 18
  • Male

Study 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

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

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

Study Design

Total Participants: 74
Treatment Group(s): 1
Primary Treatment: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
July 31, 2025

Study Description

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.

Connect with a study center

  • Lausanne University Hospital

    Lausanne, Vaud 1011
    Switzerland

    Active - Recruiting

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