Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)

Lausanne University Hospital (CHUV)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Study type: Observational

Funder types: Other

Identifiers

NCT06482489

2024-D0049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

74 participants in 3 patient groups

Healthy volunteers for protocol optimization

Description:

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.

Treatment:

Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Study of 0.55T Prostate MRI in Adult Men with Metal Implants.

Description:

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).

Treatment:

Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.

Description:

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.

Treatment:

Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).