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

NCT00464724 | Terminated

• 3 other identifiers: 2006-0516NCI-2011-00517PC061612
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Magnetic Resonance Spectroscopic Imaging; Perfluorocarbon Compound; AIR-MRSI; PFC-MRSI; 3 Tesla; MRSI; PFC

Outcome Measures

Primary Outcomes (1)

• Comparison of linewidths collected from AIR MRSI and PFC-MSRI

  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.

  2 MRSI studies should take about 60 minutes; study participation completed with prostatectomy to take place within 3 months of MRSI exams

Study Arms (1)

3T MRSI Prostate

EXPERIMENTAL

3T Magnetic Resonance Spectroscopic Imaging

Procedure: 3T Magnetic Resonance Spectroscopic Imaging

Interventions

3T Magnetic Resonance Spectroscopic Imaging PROCEDURE

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.

3T MRSI Prostate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications for MRI (e.g. cardiac pacemaker)
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• United States Department of Defense: collaborator
• GE Healthcare: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Haesun Choi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: March 1, 2007
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

US (1)