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JOURNAL ONKOLOGIE – STUDIE

Value of Ultra-fast Prostate MRI in Prostate Cancer

Rekrutierend

NCT-Nummer:
NCT05903781

Studienbeginn:
Juli 2023

Letztes Update:
08.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Zurich

Collaborator:
-

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

Prostate cancer is the second most common type of cancer among men and the fifth leading

cause of cancer-related deaths globally. Magnetic resonance imaging (MRI) has become an

integral part of the clinical assessment of prostate cancer and is a valuable tool to

identify target lesions for subsequent biopsy, perform local tumor staging, provide

information on active surveillance approaches, and might also be eligible for prostate cancer

screening.

To standardize the interpretation and reporting in prostate MRI, the PI-RADS (Prostate

Imaging-Reporting and Data System) scoring system has been developed. PI-RADS has played a

crucial role in the widespread adoption of prostate MRI among radiologists and urologists

worldwide and has also become an essential part of national and international clinical

guidelines. This has resulted in a notable surge in the number of prostate MRI examinations

conducted in recent years, and is expected to further increase over the next years. The

present PI-RADS guideline provides comprehensive technical instructions on the acquisition of

prostate MRI leading to the acquisition of a multiparametric MRI (mpMRI) that typically

requires around 30 minutes of scan time.

As healthcare systems around the world face increasing demand and limited resources, there is

a need to identify efficient and cost-effective ways to diagnose and treat prostate cancer.

Efforts have been made to reduce the duration and expenses associated with prostate MRI

acquisition and interpretation, leading to a biparametric MRI (bpMRI, exclusion of

contrast-enhanced sequences) with a shortened protocol compared to the conventional mpMRI.

Several studies have demonstrated the high diagnostic accuracy of abbreviated prostate MRI

for detecting and even staging prostate cancer in comparison to traditional full mpMRI. The

accelerated protocols have therefore the potential to improve efficiency and patient comfort,

to reduce healthcare costs and make this technique accessible to more men. Nevertheless, even

these shortened protocols accrue a scan time of about 15-20 minutes. Recent developments in

MRI technique now allow for even faster image acquisitions, but more research is necessary to

fully elicit the advantages and limitations of accelerated or even ultra-fast prostate MRI

protocols (scan time of < 5 min) before incorporating them into routine clinical practice.

The purpose of this study is therefore to further explore ultra-fast bpMRI compared to

conventional full mpMRI of the prostate to gain valuable insights into the diagnostic

performance, feasibility and clinical utility of this emerging imaging technique and

consequently optimize prostate cancer management.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients who undergo clinically indicated MR imaging of the prostate

- Informed consent as documented by signature (Informed Consent Form)

- Patients ≥18 years of age

Exclusion Criteria:

- Inability to follow the procedures of the study, e.g., due to language problems,

psychological disorders, dementia, etc. of the participant

- Previous enrolment into the current study

- Enrolment of the investigator, his/her family members, employees and other dependent

persons

- Patients with non-MRI compatible metallic or electronic implants, devices or metallic

foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or

other non-MRI compatible implants).

- Patients with known hypersensitivity reactions to MRI contrast agents will undergo the

examination without application of a contrast agent

Studien-Rationale

Primary outcome:

1. Diagnostic accuracy of ultrafast bpMRI of the prostate (Time Frame - 1.5 years):
Diagnostic accuracy of ultrafast bpMRI of the prostate

Geprüfte Regime

  • Prostate MRI:
    MRI of the prostate

Quelle: ClinicalTrials.gov


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