Ignite Creation Date:
2024-05-05 @ 11:19 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01304485
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2011-02-24
Brief Title:
PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Sponsor:
Phoenix Molecular Imaging
Organization:
Phoenix Molecular Imaging
Study Overview
Official Title:
Phase 2 Study PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma Detection of Recurrent Disease With PSA Relapse
Status:
COMPLETED
Status Verified Date:
2019-03
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:
Positron emission tomography PET imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy
Detailed Description:
The goal of this project is improved imaging of prostate cancer by positron emission tomography PET with use of the radiopharmaceutical C-11 Acetate utilizing state-of-the-art PETCT camera technology and processing algorithms
A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy
The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence post therapy rise in PSA and to evaluate the relationship between detection on C11-Acetate PET imaging PSA Trigger Velocity and Doubling Time and FDG PET imaging
Specific questions to be addressed
1 What is the yield of current state-of-the-art PETCT with C-11 Acetate in detecting recurrent disease in this patient population
2 How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose FDG-PET Sodium F18 PET bone scans and with that of CT
3 What is the optimal imaging protocol in terms of imaging time after injection
A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy
The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence post therapy rise in PSA and to evaluate the relationship between detection on C11-Acetate PET imaging PSA Trigger Velocity and Doubling Time and FDG PET imaging
Specific questions to be addressed
1 What is the yield of current state-of-the-art PETCT with C-11 Acetate in detecting recurrent disease in this patient population
2 How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose FDG-PET Sodium F18 PET bone scans and with that of CT
3 What is the optimal imaging protocol in terms of imaging time after injection
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