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3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429338
  Purpose

Objective is to evaluate the feasibility of 3T magnetic resonance spectroscopic imaging (MRSI) of the prostate in improving the spectral resolution, using a PFC-filled endorectal coil,

Specific Aim 1: To compare the spectral quality, measured in Hz (linewidth), of 3T MRSI performed with an air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil (PFC-MRSI).

Specific Aim 2: To compare the quality of spectra of PFC-MRSI by grading the overall quality of MRSI data of each patient subjectively as being "excellent," "good," "fair," "poor," and "non-diagnostic," based on the status of subjective spectral resolution of Cho, Cr and Po peaks, signal to noise ratio (SNR), baseline distortion, and fat contamination.


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

MedlinePlus related topics:   Cancer    MRI Scans    Prostate Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Feasibility Study of 3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate

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

Primary Outcome Measures:
  • To compare 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 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 ]

Estimated Enrollment:   20
Study Start Date:   January 2007
Estimated Primary Completion Date:   January 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
3T Magnetic Resonance Spectroscopic Imaging (MRSI)
Procedure: 3T Magnetic Resonance Spectroscopic Imaging
One MSRI scan performed with an air-filled endorectal coil (AIR-MRSI) and the other MSRI scan performed with a PFC-filled endorectal coil (PFC-MRSI).

Detailed Description:

MRSI is a type of magnetic resonance imaging (MRI) that uses the same type of scanner as a standard MRI. Unlike standard MRI, which takes pictures of the anatomy (body regions), MRSI takes pictures of the metabolic features of the body. Prostate cancer tissue has certain differences in its metabolism (chemical makeup) that are not seen in normal tissue. MRSI is used to detect prostate tumors by measuring the metabolic features, and an endorectal (inside of the rectum) coil is used. The coil is like an antenna.

Endorectal coils inflated with air are commonly used to detect prostate tumors and measure the status of the disease using a 1.5T (lower-powered, standard clinical) scanner. However, the accuracy of endorectal MRSI scanning still needs improvement. Researchers want to find out if the quality of endorectal MRSI scanning can be improved by using a stronger (3T) scanner and/or using PFC in the endorectal coil instead of air. PFC is a clear and odorless liquid that is known to be virtually non-toxic to the human body. It has been used as an oral contrast (swallowed by mouth) for standard MRIs. As opposed to air, PFC is physically very similar to prostate tissue, which may improve the quality of the MRSI images.

If you agree to take part in this study, you will have 2 endorectal MRSI studies (one with air and one with PFC). The MRSI study with air is diagnostic and considered standard of care, and the MRSI study with PFC is investigational. Before being inserted into your rectum, the coil will be filled with air in order to test for any leakage. You will lie on one side, inside of a 3T MRI scanner, and the coil (covered with protective latex) will be inserted into your rectum. Having the coil inserted is similar to having an enema tip inserted. The coil will be filled with air, and you will lie on your back so the first MRSI study can be completed. The study doctor will carefully check the coil to be sure it is centered at the right place to cover the entire prostate.

After the first MRSI study is completed, the air will be removed using a syringe. The coil will then be filled with PFC, and the second MRSI study will be repeated in the same manner. Once both studies are completed, the coil will be removed after the PFC is removed from the coil. There will be no direct contact between the air or PFC within the coil and your body. In total, the 2 MRSI studies should take about 60 minutes.

After the MRSI studies are completed, researchers will study the information with a special computer to compare the technical quality of the 2 sets of MRSIs. Your participation in this study will be over. Your doctor will receive a report of your diagnostic exam (the MRSI study with air).

This is an investigational study. 3T scanners and the software used for this study are FDA-approved. The use of air in the endorectal coil is a standard procedure. PFC has not yet been approved for use with an endorectal coil. MRSI/MRI equipment is commercially available and FDA-approved for routine clinical care. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

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

Criteria

Inclusion Criteria:

  1. Newly diagnosed biopsy proven prostate carcinoma who are referred to Diagnostic Imaging for MRI/MRSI
  2. No previous radiation to prostate or pelvis
  3. No hormonal treatment for prostate
  4. The interval between the biopsy and MRSI: more than 6 weeks
  5. Informed consent

Exclusion Criteria:

  1. Contraindications for MRI (e.g. cardiac pacemaker)
  2. Allergy to Latex
  3. Contraindications for MRSI (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
  6. Children (<18 years)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429338

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


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

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Haesun Choi, MD/Associate Professor )
Study ID Numbers:   2006-0333
First Received:   January 29, 2007
Last Updated:   September 29, 2008
ClinicalTrials.gov Identifier:   NCT00429338
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer  
Magnetic Resonance Imaging  
MRI  
Magnetic Resonance Spectroscopic Imaging  
MRSI  

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 October 03, 2008




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