Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00924313

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 NIH Clinical Center.

Design:

Patients have a 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 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 IV line to brighten the images.

Condition	Intervention	Phase
Prostate Cancer	Drug: (C-11 Acetate)	Phase I Phase II

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:

MedlinePlus related topics: Cancer MRI Scans Nuclear Scans Prostate Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Secondary Outcome Measures:

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)

Intervention Details:

N/A

Eligibility

Criteria

INCLUSION CRITERIA:
Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the 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 MR imaging less than or equal to 1.8mg/dl AND eGFR must be greater than 30 ml/min/1.73(m2)
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 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 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

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

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
Last Updated:	January 25, 2012
Health Authority:	United States: Federal Government

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 February 09, 2012