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

This study has been terminated.
(Slow Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429338
First received: January 29, 2007
Last updated: October 22, 2013
Last verified: October 2013

January 29, 2007
October 22, 2013
January 2007
October 2013   (final data collection date for primary outcome measure)
Spectral quality (linewidth) of 3T MRSI performed with air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil (PFC-MRSI) [ Time Frame: 60 Minutes for 2 sets of MRIs ] [ Designated as safety issue: No ]
Comparison of each linewidths (measured in Hz) between two modalities: endorectal magnetic resonance spectroscopy imaging (MRSI) of prostate using "3 Tesla (3T)" scanner with 1) perfluorocarbon compound (PFC) within endorectal coil versus 2) air.
Not Provided
Complete list of historical versions of study NCT00429338 on ClinicalTrials.gov Archive Site
Total number of patients for each grade from each group with AIR-MRSI and PFC-MRSI [ Time Frame: Patients: 60 Minutes for 2 sets of MRIs; Study Duration 4 Years ] [ Designated as safety issue: No ]
The quality of PFC-MRSI and AIR-MRSI will be graded subjectively as being "excellent," "good," "fair," "poor," and "non-diagnostic," based on the status of subjective spectral resolution of Cho, Cr, Po, and Ci peaks, signal-noise-ratio (SNR), baseline distortion, and fat and seminal vesicle contaminations.
Not Provided
Not Provided
Not Provided
 
3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate
Feasibility Study of 3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate

The objective of this study is to evaluate the feasibility of 3T magnetic resonance spectroscopic imaging (MRSI) of the prostate in improving the spectral resolution, using a perfluorocarbon compound (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.

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 for routine MRI used for this study are FDA-approved. The use of air in the endorectal coil is a standard procedure. MRSI/MRI equipment for a 1.5T scanner is commercially available and FDA-approved for routine clinical care. PFC used for this study and the software for MRSI acquisition at a 3T scanner have not been FDA-approved. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
  • Procedure: AIR-MRSI
    3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with an air-filled endorectal coil (AIR-MRSI).
    Other Names:
    • Endorectal magnetic resonance spectroscopy imaging
    • Magnetic resonance imaging
    • MRI
  • Procedure: PFC-MRSI
    3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with a perfluorocarbon compound (PFC)-filled endorectal coil (PFC-MRSI).
    Other Names:
    • Endorectal magnetic resonance spectroscopy imaging
    • Magnetic resonance imaging
    • MRI
  • Experimental: AIR-MRSI
    Endorectal MRSI with Air
    Intervention: Procedure: AIR-MRSI
  • Experimental: PFC-MRSI
    Endorectal MRSI with PFC
    Intervention: Procedure: PFC-MRSI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
Not Provided
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Newly diagnosed biopsy proven prostate carcinoma who are referred to Diagnostic Imaging for magnetic resonance imaging (MRI) / magnetic resonance spectroscopic imaging (MRSI)
  2. No previous radiation to prostate or pelvis
  3. No hormonal treatment for prostate
  4. The interval between the biopsy and magnetic resonance spectroscopic imaging (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 magnetic resonance spectroscopic imaging (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, 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, BCG for bladder cancer
  6. Children (<18 years)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00429338
2006-0333
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Haesun Choi, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP