Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating the Correlation Between C-11 Acetate Uptake and Retention as Measured by PET and FAS in Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00139191
First received: August 29, 2005
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS).


Condition Intervention
Prostate Cancer
Procedure: C-11 acetate PET scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study Evaluating the Correlation Between Carbon 11 Acetate (C-11 Acetate) Uptake and Retention as Measured by Positron Emission Tomography (PET) and Fatty Acid Synthase (FAS) Expression in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To explore the associations between measures of C-11 acetate uptake and retention into prostate tumors and levels of FAS expression in tissue.

Estimated Enrollment: 20
Study Start Date: July 2005
Study Completion Date: May 2006
Detailed Description:
  • Within 4 weeks of the patient's scheduled surgery they will undergo a C11 acetate PET scan. This scan will be performed at the Massachusetts General Hospital's Nuclear Medicine Department and involves an intravenous injection of acetate with a radioactive tracer followed by a PET scan. The scan will determine how well the tumor is taking up the acetate.
  • Patients will also undergo a CT scan of the pelvis at the same time as the PET scan.
  • After surgery, the removed tumor will have additional testing that will look at different factors that may tell us how aggressive the tumor is and how much FAS is within the tumor. FAS seems to be produced in higher amounts by prostate cancer cells than normal cells. We will then try to determine if the results of the C11 acetate PET scan can tell us how much FAS is produced by prostate cancer cells.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented prostate cancer
  • Planned radical prostatectomy
  • > 50% cores positive for prostate cancer from prostate biopsy or a palpable prostate nodule
  • Older than 18 years of age

Exclusion Criteria:

  • Inability to lay on a scanner for 60 minutes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139191

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
Principal Investigator: Robert Ross, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00139191     History of Changes
Other Study ID Numbers: 05-136
Study First Received: August 29, 2005
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Prostate Cancer
positron emission tomography
carbon 11 acetate
PET
fatty acid synthase
FAS

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014