Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)
NCT ID: NCT06482489
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
74 participants
OBSERVATIONAL
2024-11-01
2025-07-31
Brief Summary
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Detailed Description
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The goal is to find an accessible solution for prostate cancer screening while maintaining or improving image quality.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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 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).
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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Naik Vietti Violi
Principal-Investigator, Executive Physician of Diagnostic And Interventional Radiology Department
Principal Investigators
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Ileana Jelescu, Prof
Role: STUDY_CHAIR
University of Lausanne Hospitals
Locations
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Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.
Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.
Karanasios E, Caglic I, Zawaideh JP, Barrett T. Prostate MRI quality: clinical impact of the PI-QUAL score in prostate cancer diagnostic work-up. Br J Radiol. 2022 May 1;95(1133):20211372. doi: 10.1259/bjr.20211372. Epub 2022 Feb 18.
Giganti F, Allen C, Emberton M, Moore CM, Kasivisvanathan V; PRECISION study group. Prostate Imaging Quality (PI-QUAL): A New Quality Control Scoring System for Multiparametric Magnetic Resonance Imaging of the Prostate from the PRECISION trial. Eur Urol Oncol. 2020 Oct;3(5):615-619. doi: 10.1016/j.euo.2020.06.007. Epub 2020 Jul 6.
Eldred-Evans D, Burak P, Connor MJ, Day E, Evans M, Fiorentino F, Gammon M, Hosking-Jervis F, Klimowska-Nassar N, McGuire W, Padhani AR, Prevost AT, Price D, Sokhi H, Tam H, Winkler M, Ahmed HU. Population-Based Prostate Cancer Screening With Magnetic Resonance Imaging or Ultrasonography: The IP1-PROSTAGRAM Study. JAMA Oncol. 2021 Mar 1;7(3):395-402. doi: 10.1001/jamaoncol.2020.7456.
Other Identifiers
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2024-D0049
Identifier Type: -
Identifier Source: org_study_id
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