MR Fingerprinting for Diagnostic of Prostate Cancer

NCT ID: NCT05498623

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Magnetic Resonance Imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Men referred to an MR examination for prostate cancer diagnostic

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23486058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26427566 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

218665

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PET-MR-PSA Prostate Cancer Recidive Study
NCT02562131 ACTIVE_NOT_RECRUITING