Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612047
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Comparison of 50T and 30T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of 50T and 30T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer A Prospective Single Center and Paired-design Diagnostic Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5TbpMRI
Brief Summary:
The goal of this observational study is to compare 50T and 30T biparametric magnetic resonance imaging in the diagnosis of prostate cancer The main aims of this study are
Compare the diagnostic efficacy of 50TbpMRI and 30TbpMRI for prostate cancer Preliminarily evaluate the value of 50TbpMRI in diagnosing prostate cancer
Compare and analyze the accuracy of 50TbpMRI and 30TbpMRI in determining the T stage of prostate cancer Preliminary evaluation of the value of 50TbpMRI in determining the tumor stage of prostate cancer
The data of participants was collected prospectively
Compare the diagnostic efficacy of 50TbpMRI and 30TbpMRI for prostate cancer Preliminarily evaluate the value of 50TbpMRI in diagnosing prostate cancer
Compare and analyze the accuracy of 50TbpMRI and 30TbpMRI in determining the T stage of prostate cancer Preliminary evaluation of the value of 50TbpMRI in determining the tumor stage of prostate cancer
The data of participants was collected prospectively
Detailed Description:
The methods currently recommended by the guidelines for early diagnosis of prostate cancer mainly include rectal examination serum prostate-specific antigen detection transrectal prostate ultrasound and multi-parameter magnetic resonance imaging However these methods lack sufficient specificity for the diagnosis of prostate cancer Therefore prostate biopsy is still the gold standard for the diagnosis of prostate cancer mpMRI has good accuracy in detecting clinically significant prostate cancer but mpMRI is difficult to identify lesions with a tumor diameter of less than 5 mm and false positive results may occur for benign diseases such as prostatitis The magnetic field strength of mpMRI magnetic resonance scanners commonly used in clinical practice is mostly 15T or 30T The application of 30T magnetic resonance allows patients to no longer accept the use of rectal coils and makes the examination images clearer making it the most commonly used magnetic field strength for mpMRI The main problems of 30T prostate magnetic resonance examinations are low specificity false positive results and insufficient accuracy in determining tumor staging At present there is no research and exploration on the use of 50T magnetic resonance in the diagnosis of prostate cancer in the world This study intends to analyze and compare the differences between 50TbpMRI and 30TbpMRI in the diagnosis of prostate cancer through a prospective paired-design diagnostic trial and try to explore whether 50TbpMRI can improve the limitations of 30TbpMRI in the diagnosis of prostate cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None