Clinical trial NCT05498623: MR Fingerprinting for Diagnostic of Prostate Cancer
Official title: MR Fingerprinting of the Prostate - Towards Improved Patient Care with High Speed Quantitative Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Magnetic Resonance Imaging
Keywords: MR Fingerprinting
Prostate Cancer
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2022-08-12
Enrollment: 203
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers will be recruited among students and employees at NTNU/St. Olavs Hospital. The possibility to participate will be announced on internal WEB-pages and on bulletin boards at Øya Campus.

Patients referred to mp-MRI due to suspicion of prostate cancer will receive information about the study and the informed consent form together with the letter they receive from Clinic of Radiology with their appointment for the MRI examination.

Brief summary: The diagnostic pathway for suspected prostate cancer relies greatly on radiological imaging. Establishment of magnetic resonance fingerprinting (MRF) has the potential to significantly improve patient experience and outcomes. MRF is a novel and innovative approach to a long-standing challenge of recording and reconstructing MR image

The aim is to conduct a clinical pilot study in which patients will be scanned using the newly refined MRF sequence in addition to the conventional scanning protocols.

Detailed description: The patient is at the center of all medical interventions and innovations. For those with prostate cancer, the pathway for new patients has scope for improvement. MRI is an important and necessary part of that pathway, but scanning capacity is often stretched, and there is need for effective and efficient scan techniques. Beyond mere detection of lesions, the modality has potential to differentiate and categorize the clinical significance of prostate cancer. By virtue of quantitative imaging, the determination of biomarkers could lead to a non-invasive method of prostate cancer diagnosis. The Prostate Imaging Reporting and Data System (PIRADS) scoring is a standardized system of acquiring and categorizing multi-parametric-MR images (mp-MRI) of the prostate. The PIRADS system works to grade to clinical significance of prostate cancer, however this relies on qualitative information.

Patients referred for a typical MRI of the prostate will in addition receive the MR Fingerprinting scan, which will add about 8 minutes to their time on the scanner. The direct comparison of the fingerprint maps and multi-parametric images can then be made. Conclusions will be drawn with focus to potential improvement of the PIRADS protocol.

The main aim of the project is therefor to implement, validate, and optimize sequences for MR Fingerprinting of the prostate.

Eligibility criteria: Inclusion Criteria:

- Men referred to an MR examination for prostate cancer diagnostic

Exclusion Criteria:

- None

Primary outcomes:
measure: MRF compared to T1, T2 and proton density generated to the PIRADS scoring
timeFrame: an average of 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
References:
citation: Ma D, Gulani V, Seiberlich N, Liu K, Sunshine JL, Duerk JL, Griswold MA. Magnetic resonance fingerprinting. Nature. 2013 Mar 14;495(7440):187-92. doi: 10.1038/nature11971.
citation: Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.