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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00464724

Purpose

Objectives:

evaluate the feasibility of 3T MRSI of prostate in improving the spectral resolution, using a PFC-filled endorectal coil,
develop a systematic metabolic grading system for tumor detection by identifying the abnormal peak areas of Cho, Cr, Po, and Ci for the prostate carcinoma, specifically from PFC-filled endorectal 3T MRSI, and
evaluate the efficacy of the metabolic grading system in tumor detection.

The long-term goal of the study is to provide an early prognostic indicator and means of monitoring the biologic status of the prostate cancer during the course of the disease.

Specific Aims:

Phase I - Feasibility study

- To compare the linewidth measured in Hz, numbers of voxels that clearly resolve the Cho, Po, Cr, and Ci peaks between the air-filled endorectal MRSI (AIR-MRSI) and PFC-filled endorectal MRSI (PFC-MRSI) of prostate in a total of 40 patients with biopsy-proven prostate carcinomas.

Phase I/II

Development of a metabolic grading system in detecting the prostate tumor on 3T PFC-MRSI.
Establish first the Cho, Cr, and Ci peak areas and the ratios of (Cho+Cr)/Ci and Cho/Cr peak areas in the tumor and normal tissues identified from the prostatectomy specimen. The metabolic peak area ratios will then be graded using a 5 point grading system, with 5 being definite tumor and 1 being definite normal. The presence of Po peak will also be recorded and correlated with the histopathology from the prostatectomy specimen.

Phase II - Efficacy study

To evaluate efficacy of the metabolic grading system specifically developed, for 3T PFC-MRSI.
The metabolic grades obtained from 3T PFC-MRSI will be correlated with the pathologic staging and tumor grades following prostatectomy as well as serum PSA levels, Gleason scores, and clinical staging at the time of diagnosis. For this study, another 40 patients with biopsy-proven prostate carcinomas will be selected.

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

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate

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

Primary Outcome Measures:

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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The grading system will also be tested for its effectiveness in improving the detection of prostate tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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, TURP and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, 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
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Haesun Choi, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Haesun Choi, MD

U.T.M.D. Anderson Cancer Center

More Information

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

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Haesun Choi, MD/Associate Professor )
Study ID Numbers:	2006-0516
Study First Received:	April 23, 2007
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00464724
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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009