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Study Summary
No. 2006-0516:.......Genitourinary......Haesun Choi......Diagnostic Radiology
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Study Summary Title
Study Summary
Number:		2006-0516
Study Title:3T Perfluorocarbon-filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
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Physician New Patient Referral
Name:Haesun ChoiPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Diagnostic RadiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4693
Contact us about clinical trials
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General Information
Disease Group:GenitourinarySupported By:N/A
Phase of Study:N/AReturn
Visit:		NA
Treatment
Agents:		NoneHome Care:NA
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		NA
Description/
Intervention:		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.
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Study Objectives / Outcomes
The objectives of this study are to: 1) evaluate the feasibility of 3T MRSI of prostate in improving the spectral resolution, using a PFC-filled endorectal coil, 2) 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 3) 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.
We will first establish 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.
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Study Status Information
Study Activation / Registration Date:03/27/2007
IRB Review and Approval Date:10/25/2006
Study Type:Other
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Biopsy proven, clinical stage 1-3 prostate carcinomas

2) Prostatectomy at M. D. Anderson within 3 months from the time of MRSI

3) An interval of > 6 weeks between the biopsy and MRSI

4) Signed informed consent form
Exclusion Criteria:1) Contraindications for MRI (e.g. cardiac pacemaker)

2) Allergy to Latex

3) Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)

4) Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field

5) 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
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Links
Registration Number: NCT00464724
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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