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.
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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. — 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.
Trial sites (1)
Facility
City
Region
Status
Lausanne University Hospital
Lausanne
Canton of Vaud
Recruiting
More University of Lausanne Hospitals trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
