3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Department of Defense
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00464724

Purpose

The goal of this clinical research study is to compare the technical quality of 2 ways of performing endorectal magnetic resonance spectroscopy imaging (MRSI) of the prostate, using a "3 Tesla (3T)" scanner. This is the first of a 2-part study. In Part 1, researchers will compare the use of perfluorocarbon compound (PFC) within the endorectal coil with the use of air in order to try to find out which technique may help to produce better-quality images. Researchers will also develop a "grading" system for diagnosing prostate cancer based on the changes in metabolic features at 3T scanners. The grading system will help researchers to label the prostate tissue (such as Grade 1, 2, or 3) in terms of whether or not there is a tumor and, if so, how aggressive the tumor is. In Part 2, the grading system will also be tested for its effectiveness in improving the detection of prostate tumors. The results of the experimental diagnostic grading system will be compared with the pathologist's results after the prostatectomy you will have as part of your standard of care.

Condition	Intervention
Prostate Cancer	Procedure: 3T Magnetic Resonance Spectroscopic Imaging

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:	3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Comparison of linewidths collected from AIR MRSI and PFC-MSRI [ Time Frame: 2 MRSI studies should take about 60 minutes; study participation completed with prostatectomy to take place within 3 months of MRSI exams ] [ Designated as safety issue: No ]
The outcome variable for comparing linewidths between the two modalities is paired differences of measurements taken from the same patients. A paired t-test is used to test for a 50% decrease in the mean linewidth as measured by PFC-MRSI versus AIR-MRSI.

Estimated Enrollment:	80
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 3T MRSI Prostate 3T Magnetic Resonance Spectroscopic Imaging	Procedure: 3T Magnetic Resonance Spectroscopic Imaging Part 1 of Study = One MRSI exam with an air-filled endorectal coil (AIR-MRSI) and one with a PFC-filled endorectal coil (PFC-MRSI); Part 2 of Study = MRSI exam with PFC using an endorectal coil only.

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Eligibility

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

Criteria

Inclusion Criteria:

Biopsy proven, clinical stage 1-3 prostate carcinomas
Prostatectomy at M. D. Anderson within 3 months from the time of MRSI
An interval of > 6 weeks between the biopsy and MRSI
Signed informed consent form

Exclusion Criteria:

Contraindications for MRI (e.g. cardiac pacemaker)
Allergy to Latex
Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
Previous prostate surgery for prostate carcinoma (including, Transurethral resection of the prostate (TURP) and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, Bacillus Calmette-Guerin (BCG) for bladder cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464724

Contacts

Contact: Haesun Choi, MD

713-745-4693

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Haesun Choi, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Department of Defense

Investigators

Principal Investigator:

Haesun Choi, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00464724 History of Changes
Other Study ID Numbers:	2006-0516
Study First Received:	April 23, 2007
Last Updated:	December 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Prostate Cancer
Magnetic Resonance Spectroscopic Imaging
Perfluorocarbon Compound
AIR-MRSI

PFC-MRSI
3 Tesla
MRSI
PFC

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 May 22, 2012