Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00924313
First received: June 17, 2009
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

Background:

  • Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans.
  • An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor cells and may help find prostate cancers more accurately than other imaging methods.

Objectives:

  • To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate.

Eligibility:

  • Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.

Design:

  • Patients have a positron emission tomography (PET scan). For this test, an intravenous (IV) line is placed in the patient's arm and the patient lies on a table inside the donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and images of the lower pelvis and abdomen are obtained over 30 minutes.
  • Patients have an endorectal coil MRI scan. For this test, a tube is placed in the rectum, just behind the prostate, to increase the amount of signal received by the magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on the scanning table for about 75 to 90 minutes while images are obtained. During the scan, a contrast agent called gadolinium is injected through an intravenous (IV) line to brighten the images.

Condition Intervention Phase
Prostate Cancer
Drug: (C-11 Acetate)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of 11C-Acetate Positron Emission Tomography (PET) and 3 Telsa Magnetic Resonance Imaging (MRI) in Men With Prostate Cancer Undergoing Prostatectomy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.


Enrollment: 40
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11C-acetate for Prostate Cancer Patients
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
Drug: (C-11 Acetate)
11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
  • Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.
  • Participant must be 18 years or older.
  • Serum creatinine within 1 week prior to magnetic resonance (MR) imaging less than or equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73 m^2
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.
  • Ability to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

EXCLUSION CRITERIA:

  • Known allergy to gadolinium or acetate.
  • Participants for whom participating would significantly delay the scheduled standard of care therapy.
  • Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
  • Participants with severe claustrophobia.
  • Patients with contraindications to magnetic resonance imaging (MRI)
  • Patients weighing greater than 136 kg (weight limit for scanner table).
  • Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
  • Patients with contraindication to endorectal coil placement
  • Severe hemorrhoids.
  • Surgically absent rectum.
  • Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol procedures.
  • Patients who have previously received radiation therapy to the pelvis.
  • Patients who have received androgen deprivation therapy.
  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: NCT00924313

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Peter L Choyke, M.D. National Cancer Institute, National Institutes of Health
  More Information

Publications:
Responsible Party: Peter L. Choyke, M.D./NIH Clinical Center, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00924313     History of Changes
Obsolete Identifiers: NCT00771550
Other Study ID Numbers: 080226, 08-C-0226
Study First Received: June 17, 2009
Results First Received: July 12, 2012
Last Updated: July 12, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
Prostate Cancer
MRI
C-11 Acetate
PET

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

ClinicalTrials.gov processed this record on August 26, 2014