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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 : Completed
First Posted : February 25, 2011
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Fabio Almeida MD, Phoenix Molecular Imaging

Tracking Information
First Submitted Date  ICMJE February 24, 2011
First Posted Date  ICMJE February 25, 2011
Last Update Posted Date March 7, 2019
Study Start Date  ICMJE April 2011
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
PSA (prostate specific antigen) [ Time Frame: Every 3months for 24 months after PET imaging ]
PSA will be monitored per routine clinical follow-up.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Official Title  ICMJE Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
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 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?
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: Sodium Acetate C11
PET Imaging with Sodium Acetate C11
Other Names:
  • Carbon 11 Acetate PET
  • C11 Acetate
  • AC-PET
Study Arms  ICMJE Experimental: Sodium Acetate C11 PET Imaging
Intervention: Drug: Sodium Acetate C11
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
2000
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2011)
200
Actual Study Completion Date  ICMJE January 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01304485
Other Study ID Numbers  ICMJE AMIC-AC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Journal Publication
Responsible Party Fabio Almeida MD, Phoenix Molecular Imaging
Study Sponsor  ICMJE Phoenix Molecular Imaging
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fabio Almeida, M.D. Medical Director, Phoenix Molecular Imaging
PRS Account Phoenix Molecular Imaging
Verification Date March 2019

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