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Recruiting
NCT06482489
Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Enrollment: 74
Sponsor: University of Lausanne Hospitals
Location: Lausanne University Hospital Lausanne Canton of Vaud
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 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
Source: ClinicalTrials.gov (NCT06482489). StuddyBuddy aggregates publicly available trial information.