NCT05498623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

July 5, 2022

Last Update Submit

October 30, 2024

Conditions

Keywords

MR FingerprintingProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related 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.

    PMID: 23486058BACKGROUND
  • 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.

    PMID: 26427566BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

August 12, 2022

Study Start

September 1, 2022

Primary Completion

February 28, 2023

Study Completion

March 15, 2023

Last Updated

November 1, 2024

Record last verified: 2024-10

Locations