Prostate Cancer
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICESiemens 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.
Sponsors
University of Lausanne Hospitals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protocol optimization on healthy volunteers | 1 month | Assess image quality at 3T MRI and optimize the trade-off between quality and scan time. |
| Image quality on patients with metal implants | 9 months | Compare 0.55T and 3T MRI image quality in patients with implants and suspected prostate cancer, assessing PI-QUAL scaling. |
Countries
Switzerland
Contacts
Primary ContactNaïk Vietti-Violi, Dre
Backup ContactGorun Ilanjian, Dr
Outcome results
None listed