An observational study in Prostate Cancer, sponsored by University of Lausanne Hospitals. Recruiting at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University of Lausanne Hospitals · Observational
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.
The investigators initiate the study by establishing a specialized Low-Field MRI protocol. 23 healthy volunteers participate in this phase undergoing a 0.55T MRI to refine imaging sequences for prostate cancer screening. The objective is to optimize these sequences ensuring diagnostic quality on par with the standard 3T MRI, comparing technical settings such as SNR and CNR from healthy volunteers and the retrospective 3T prostate MRI cohort.
In WP2, 0.55T MRI exam will be performed on 20 patients who had a previous 3T MRI with a sub-diagnostic prostate MRI, using metrics of SNR, CNR, DWI and the PI-QUAL scaling score due to metallic implants.
In WP3, 31 eligible and enrolled patients who have a PI-RADS 4 or 5 lesion detected during a clinical 3T MRI exam with scheduled targeted prostate biopsy will undergo an additional MRI exam at 0.55T (before the biopsy).
Work Package1 (WP): 0.55T MRI Protocol Development
WP2: 0.55T Prostate MRI with patients with metallic implant(s)
WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
Exclusion Criteria:
WP1: 0.55T MRI Protocol Development
WP2: 0.55T Prostate MRI with patients with metallic implant(s)
WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
The commencement of the study involves the formulation of the 0.55T MRI protocol. For this purpose, a cohort of 23 male volunteers will undergo a 0.55T MRI. The objective is to achieve the same spatial resolution and coverage as observed at 3T.
Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
The second phase of the research will be carried out to compare the MRI image quality between 0.55T and 3T MRI. The study will involve 20 adult men, who on 3T prostate MRI, have DWI reported as sub-diagnostic (PI-QUAL \< 3) due to the presence of metallic implant(s).
Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
The third phase includes 31 patients whose 3T MRIs detected lesions classified as PI-RADS 4/5 and who are scheduled for targeted prostate biopsy.
Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
Performing low-field MRI to evaluate image quality with patients carrying metallic implants and assess the detection of suspicious prostate lesions.
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
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
Plan to share: Yes — eCRF on RedCap Software
Supporting information: Study protocol, Icf
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University of Lausanne Hospitals