PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
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|ClinicalTrials.gov Identifier: NCT01304485|
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Sodium Acetate C11||Phase 2|
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 PET/CT 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:
- What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?
- 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?
- What is the optimal imaging protocol in terms of imaging time after injection?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
|Experimental: Sodium Acetate C11 PET Imaging||
Drug: Sodium Acetate C11
PET Imaging with Sodium Acetate C11
- SUV (Standardized Uptake Value) [ Time Frame: Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration ]Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
- PSA (prostate specific antigen) [ Time Frame: Every 3 - 6 months for 24 months after PET imaging ]PSA will be monitored per routine clinical follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304485
|United States, Arizona|
|Phoenix Molecular Imaging|
|Phoenix, Arizona, United States, 85040|
|Principal Investigator:||Fabio Almeida, M.D.||Medical Director, Phoenix Molecular Imaging|