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NCT Number: NCT06482489

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location status: Recruiting

Location contact

Naïk Vietti Violi, MD

CONTACT

[email protected]

+41795560240

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Time frame: 9 months

    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.

Secondary outcomes

  1. Protocol optimization on healthy volunteers

    Time frame: 1 month

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

  2. Image quality on patients with metal implants

    Time frame: 9 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gorun Ilanjian, Dr

CONTACT

[email protected]

0795560232 ext. +41

Naïk Vietti-Violi, Dre

CONTACT

[email protected]

0795560240 ext. +41

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Comparing Prostate Cancer Screening Between Standardized 3T MRI Screening Protocol and Low-Field MRI in a Prospective Study

Acronym: Low-PRISM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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