Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)
Recruiting · NCT06482489 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Lausanne Hospitals
View the official record on ClinicalTrials.gov →Interventions studied
Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Lausanne University Hospital - Lausanne, Canton of Vaud, Switzerland