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

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ClinicalTrials.gov Identifier: NCT00464724
Recruitment Status : Recruiting
First Posted : April 24, 2007
Last Update Posted : February 21, 2018
Sponsor:
Collaborators:
United States Department of Defense
GE Healthcare
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Objectives:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: 3T Magnetic Resonance Spectroscopic Imaging Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
Actual Study Start Date : March 2007
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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. Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
  3. Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
  4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464724


Contacts
Contact: Haesun Choi, MD 713-745-4693

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Haesun Choi, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
United States Department of Defense
GE Healthcare
Investigators
Principal Investigator: Haesun Choi, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00464724     History of Changes
Other Study ID Numbers: 2006-0516
NCI-2011-00517 ( Registry Identifier: NCI CTRP )
PC061612 ( Other Identifier: DOD )
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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