Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Lausanne Hospitals
About this trial
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
This trial does not accept healthy volunteersQualifiers
Healthy male volunteers aged 18 and above.
Agree to be contacted for incidental findings
Signed informed consent
Adult men (≥18 y.o) with 3T MRI reported as sub-diagnostic due to metallic implants
Disqualifiers
Individuals with a history of prostate cancer
MR Contraindications as listed in the MR Safety Screening form
Contraindications as per MD instructions
Any condition making the patient unsuitable for the study
Trial population
The investigators initiate the study by establishing a specialized Low-Field MRI protocol. 23 healthy volunteers participate in this phase undergoing a 0.55T MRI to refine imaging sequences for prostate cancer screening. The objective is to optimize these sequences ensuring diagnostic quality on par with the standard 3T MRI, comparing technical settings such as SNR and CNR from healthy volunteers and the retrospective 3T prostate MRI cohort. In WP2, 0.55T MRI exam will be performed on 20 patients who had a previous 3T MRI with a sub-diagnostic prostate MRI, using metrics of SNR, CNR, DWI and the PI-QUAL scaling score due to metallic implants. In WP3, 31 eligible and enrolled patients who have a PI-RADS 4 or 5 lesion detected during a clinical 3T MRI exam with scheduled targeted prostate biopsy will undergo an additional MRI exam at 0.55T (before the biopsy).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
DevicePerforming low-field MRI to evaluate image quality with patients carrying metallic implants and assess the detection of suspicious prostate lesions.
Treatment groups
74 Participants
are divided into 3 treatment groupsGroup A: Healthy volunteers for protocol optimization1 intervention
Group B: Study of 0.55T Prostate MRI in Adult Men with Metal Implants.1 intervention
Group C: Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.1 intervention
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
9 monthsSecondary outcomes
1
Protocol optimization on healthy volunteers
Assess image quality at 3T MRI and optimize the trade-off between quality and scan time.
Time frame
1 month2
Image quality on patients with metal implants
Compare 0.55T and 3T MRI image quality in patients with implants and suspected prostate cancer, assessing PI-QUAL scaling.
Time frame
9 monthsSponsors and contacts
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Source ClinicalTrials.gov