Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-28
Brief Title:
Dynamic 68Ga-PSMA and 18F-FDG PETCT Analysis Prior to 177Lu-PSMA
Sponsor:
Centre Henri Becquerel
Organization:
Centre Henri Becquerel
Study Overview
Official Title:
Dynamic 68Ga-PSMA and 18F-FDG PETCT Analysis of Metastatic Prostatic Adenocarcinomas Prior to 177Lu-PSMA Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
PYPET
Brief Summary:
Prostate cancer is a significant health issue representing 218 of male cancer cases in France with over 449000 new cases in 2018 Its the cause of 10 of cancer deaths in Europe
The PSMA is a target for mCRPC treatment with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells The Vision study showed that 177Lu-PSMA-617 combined with standard care improved survival rates significantly compared to standard care aloneThe French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions Patients must have histologically confirmed mCRPC be progressive despite treatment and have PSMA-positive imaging
Imaging assessments include PSMA PETCT and 18F-FDG PETCT to identify FDG-positive and PSMA-negative sites which are associated with a poorer prognosis
Parametric analysis using dynamic PET could improve lesion characterization aiding in treatment decisions This is the focus of the PyPET study
The main objective focuses on a comparative analysis of data from dynamic parametric analysis metabolic influx rate Ki volume of distribution Vd and static analysis standard at 1 hour using 18F-FDG and 68Ga-PSMA PETCT for diagnosing metastases especially in the liver lymph nodes and bones It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites
The PSMA is a target for mCRPC treatment with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells The Vision study showed that 177Lu-PSMA-617 combined with standard care improved survival rates significantly compared to standard care aloneThe French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions Patients must have histologically confirmed mCRPC be progressive despite treatment and have PSMA-positive imaging
Imaging assessments include PSMA PETCT and 18F-FDG PETCT to identify FDG-positive and PSMA-negative sites which are associated with a poorer prognosis
Parametric analysis using dynamic PET could improve lesion characterization aiding in treatment decisions This is the focus of the PyPET study
The main objective focuses on a comparative analysis of data from dynamic parametric analysis metabolic influx rate Ki volume of distribution Vd and static analysis standard at 1 hour using 18F-FDG and 68Ga-PSMA PETCT for diagnosing metastases especially in the liver lymph nodes and bones It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites
Detailed Description:
None
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