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

This study is currently recruiting participants.
Verified February 2017 by Fabio Almeida MD, Phoenix Molecular Imaging
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304485
First Posted: February 25, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Fabio Almeida MD, Phoenix Molecular Imaging
  Purpose
Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

Condition Intervention Phase
Prostate Cancer Drug: Sodium Acetate C11 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse

Resource links provided by NLM:


Further study details as provided by Fabio Almeida MD, Phoenix Molecular Imaging:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1500
Study Start Date: April 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Acetate C11 PET Imaging Drug: Sodium Acetate C11
PET Imaging with Sodium Acetate C11
Other Names:
  • Carbon 11 Acetate PET
  • C11 Acetate
  • AC-PET

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?
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Fabio Almeida, MD 520-661-5125 falmeida@phxmi.com
Contact: Elisa Blackwell, CRC eblackwell@phxmi.com

Locations
United States, Arizona
Phoenix Molecular Imaging Recruiting
Phoenix, Arizona, United States, 85040
Principal Investigator: Fabio Almeida, MD         
Sponsors and Collaborators
Phoenix Molecular Imaging
Investigators
Principal Investigator: Fabio Almeida, M.D. Medical Director, Phoenix Molecular Imaging
  More Information

Responsible Party: Fabio Almeida MD, Fabio Almeida MD, Medical Director, Phoenix Molecular Imaging
ClinicalTrials.gov Identifier: NCT01304485     History of Changes
Other Study ID Numbers: AMIC-AC-001
First Submitted: February 24, 2011
First Posted: February 25, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Journal Publication

Keywords provided by Fabio Almeida MD, Phoenix Molecular Imaging:
Recurrent Prostate Carcinoma
sodium acetate c11
PET
prostate cancer
rising PSA
PSA recurrence
biochemical recurrence

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases