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Comparing Prostate Cancer Screening Between Standardized 3T MRI Screening Protocol and Low-Field MRI in a Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
View:

⁃ 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

Locations
Other Locations
Switzerland
Lausanne University Hospital
RECRUITING
Lausanne
Contact Information
Primary
Naïk Vietti-Violi, Dre
Naik-Vietti-Violi@chuv.ch
0795560240
Backup
Gorun Ilanjian, Dr
Gorun.Ilanjian@chuv.ch
0795560232
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 74
Treatments
Healthy volunteers for protocol optimization
The commencement of the study involves the formulation of the 0.55T MRI protocol. For this purpose, a cohort of 23 male volunteers will undergo a 0.55T MRI. The objective is to achieve the same spatial resolution and coverage as observed at 3T.
Study of 0.55T Prostate MRI in Adult Men with Metal Implants.
The second phase of the research will be carried out to compare the MRI image quality between 0.55T and 3T MRI. The study will involve 20 adult men, who on 3T prostate MRI, have DWI reported as sub-diagnostic (PI-QUAL \< 3) due to the presence of metallic implant(s).
Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.
The third phase includes 31 patients whose 3T MRIs detected lesions classified as PI-RADS 4/5 and who are scheduled for targeted prostate biopsy.
Related Therapeutic Areas
Sponsors
Leads: University of Lausanne Hospitals

This content was sourced from clinicaltrials.gov