Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504017
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
FUS-TB VS COG-TB in Small Lesions of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
FUS-TB VS COG-TB in Prostate Cancer With PI-RADS 4 Small Lesions - a Predictive Multi-center Exploring Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
To compare the positive detection rates of COG-TB vs FUS-TB for prostate cancer with PI-RADS 4 small lesions
Detailed Description:
Prostate cancer PCA is the most frequent malignancy in male urogenital system According to the World Health Organizations 2020 GLOBOCAN statistics there are approximately 14 million new cases and 375000 deaths worldwide PCa is the second most common tumor in male patients after lung cancer and ranks fifth among cancer causes of death
Currently prostate specific antigen PSA digital rectal examination DRE multi-parametric magnetic resonance imaging mpMRI prostate specific membrane antigen positron emission Tomographycomputed tomography PSMA PETCT and other detection methods have played an important role in the diagnosis of PCa but the gold standard for confirming PCa is the histopathological examination of prostate biopsy Performing mpMRI before biopsy can help detect and locate prostate cancer with ISUP grade 2 Studies have shown that the prostate imaging reporting and data system PI-RADS may help improve the detection of clinically significant cancers Biopsy should be considered when PI-RADS score 4 or 5
This clinical study intends to use the mpMRI-TRUS image fusion ultrasound system to assist in guiding FUS-TB comparing to COG-TB to evaluate the application value of mpMR-TRUS image fusion in the detection of PCa in prostate biopsy
Currently prostate specific antigen PSA digital rectal examination DRE multi-parametric magnetic resonance imaging mpMRI prostate specific membrane antigen positron emission Tomographycomputed tomography PSMA PETCT and other detection methods have played an important role in the diagnosis of PCa but the gold standard for confirming PCa is the histopathological examination of prostate biopsy Performing mpMRI before biopsy can help detect and locate prostate cancer with ISUP grade 2 Studies have shown that the prostate imaging reporting and data system PI-RADS may help improve the detection of clinically significant cancers Biopsy should be considered when PI-RADS score 4 or 5
This clinical study intends to use the mpMRI-TRUS image fusion ultrasound system to assist in guiding FUS-TB comparing to COG-TB to evaluate the application value of mpMR-TRUS image fusion in the detection of PCa in prostate biopsy
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