NCT06482489Recruiting
Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland
- Sponsor
- University of Lausanne Hospitals(Other)
- Protocol no.
- 2024-D0049
- Conditions
- Prostate Cancer
- Interventions
- Device
Treatments studied
- Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
Locations · 1
- Lausanne, SwitzerlandLausanne University HospitalRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: April 3, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.