Ignite Creation Date:
2024-07-17 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484361
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-03-22
Brief Title:
PETMRI to Stage Prostate Cancer Patients
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Phase II Monocentric Study to Evaluate a Novel Approach for Staging Prostate Cancer Patients by Using a Fully Integrated Hybrid PETMRI
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of this phase II clinical trial is to define a novel approach of staging prostate cancer PCa patients by using a fully integrated positron emission tomography magnetic resonance imaging PETMRI system with 68Ga-prostate specifica membrane antigen PSMA and 68Ga-RM2 bombesin antagonist
50 patients with biopsy proven PCa will be studied by PETMRI with 68Ga-PSMA and with 68Ga-RM2 and then will undergo prostatectomy and pelvic lymphadenectomy
50 patients with biopsy proven PCa will be studied by PETMRI with 68Ga-PSMA and with 68Ga-RM2 and then will undergo prostatectomy and pelvic lymphadenectomy
Detailed Description:
This is a prospective monocentric open study Phase II study The study will include 50 consecutive PCa patients who will be recruited in the first 36 months of the study All clinical and pathological variables available at the time of PETMRI will be recorded for each patient and all patients will take a blood sample before the first PETMRI study All patients will undergo 68Ga-PSMA and 68Ga-RM2 PETMRI studies at San Raffaele Hospital in two different days 48 hours between the two studies and within one month from each other
Then patients will undergo surgical intervention prostatectomy and pelvicretroperitoneal lymphadenectomy and the surgically removed prostate will be fixated and processed Ex-vivo 3T-MRI study will be performed on the processed specimen prostate gland and afterwards the prostate will be examined by a dedicated pathologist Spatial coregistration of in vivo ex-vivo and histopathological images will be performed so that the annotation dominant tumor lesion made by the pathologist will be translated onto in vivo PETMR images and semi-quantitative and radiomic features will be extracted from PET and mp-MRI images
Then patients will undergo surgical intervention prostatectomy and pelvicretroperitoneal lymphadenectomy and the surgically removed prostate will be fixated and processed Ex-vivo 3T-MRI study will be performed on the processed specimen prostate gland and afterwards the prostate will be examined by a dedicated pathologist Spatial coregistration of in vivo ex-vivo and histopathological images will be performed so that the annotation dominant tumor lesion made by the pathologist will be translated onto in vivo PETMR images and semi-quantitative and radiomic features will be extracted from PET and mp-MRI images
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None