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:
-
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.
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
Primary outcome:
1. Diagnostic accuracy of ultrafast bpMRI of the prostate (Time Frame - 1.5 years):
Diagnostic accuracy of ultrafast bpMRI of the prostate
- Prostate MRI:
MRI of the prostate
Quelle: ClinicalTrials.gov
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