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PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma

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ClinicalTrials.gov Identifier: NCT01304485
Recruitment Status : Recruiting
First Posted : February 25, 2011
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Fabio Almeida MD, Phoenix Molecular Imaging

February 24, 2011
February 25, 2011
February 23, 2017
April 2011
April 2018   (Final data collection date for primary outcome measure)
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.
SUV (Standardized Uptake Value) [ Time Frame: 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.
Complete list of historical versions of study NCT01304485 on ClinicalTrials.gov Archive Site
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.
PSA (prostate specific antigen) [ Time Frame: Every 3months for 24 months after PET imaging ]
PSA will be monitored per routine clinical follow-up.
Not Provided
Not Provided
 
PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

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:

  1. What is the yield of current state-of-the-art PET/CT 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?
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Prostate Cancer
Drug: Sodium Acetate C11
PET Imaging with Sodium Acetate C11
Other Names:
  • Carbon 11 Acetate PET
  • C11 Acetate
  • AC-PET
Experimental: Sodium Acetate C11 PET Imaging
Intervention: Drug: Sodium Acetate C11
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
200
April 2018
April 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)

Exclusion Criteria:

  • < 18 years old
  • claustrophobic patients
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact: Fabio Almeida, MD 520-661-5125 falmeida@phxmi.com
Contact: Elisa Blackwell, CRC eblackwell@phxmi.com
United States
 
 
NCT01304485
AMIC-AC-001
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Journal Publication
Fabio Almeida MD, Phoenix Molecular Imaging
Phoenix Molecular Imaging
Not Provided
Principal Investigator: Fabio Almeida, M.D. Medical Director, Phoenix Molecular Imaging
Phoenix Molecular Imaging
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP