MR Fingerprinting for Diagnostic of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

MR Fingerprinting of the Prostate - Towards Improved Patient Care With High Speed Quantitative Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05498623
• Other study ID #: 218665
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 203
• Est. completion date: December 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Men referred to an MR examination for prostate cancer diagnostic

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRF compared to T1, T2 and proton density generated to the PIRADS scoring	MR Fingerprinting has proven to reduce scan time by acquiring property maps simultaneously. MRF uses pseudorandom, rapidly switching pulses to elicit a unique signal evolution - hence the term fingerprint. This "fingerprint" signal is matched to a predefined dictionary of all possible signal evolutions and so multiple measurements are acquired simultaneously. Since the values such as T1, T2 and proton density are matched and not interpolated, the method is far more quantitative than conventional MRI.	an average of 30 minutes