Magnetic Resonance (MR) Spectroscopy in Localized Prostate Cancer

July 14, 2016 updated by: AHS Cancer Control Alberta

MR Spectroscopy in Localized Prostate Cancer

This study is designed to investigate whether filling the rectum with high density barium prior to a magnetic resonance spectroscopy (MRS)exam of the prostate improves the quality of the acquired spectrum. It is expected that the dense substance should help prevent air from entering the rectum and thus susceptibility artifacts in the obtained MRS data should be reduced. Ten patients with localized prostate cancer will be recruited for this study. There will be no change in treatment planning based on MRS study. Patient will receive standard radiation treatment prescribed by radiation oncologist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to investigate whether filling the rectum with high density barium prior to a magnetic resonance spectroscopy (MRS) exam of the prostate improves the quality of the acquired spectrum. It is expected that the dense substance should help prevent air from entering the rectum and thus susceptibility artifacts in the obtained MRS data should be reduced. Ten patients with localized prostate cancer will be recruited for this study. There will be no change in treatment planning based on MRS study. Patient will receive standard radiation treatment prescribed by radiation oncologist.

An MRS study of each patient's prostate will be conducted with the 3 Tesla Philips Intera NMR (Nuclear Magnetic Resonance) scanners before and after filling the rectum with barium. Patients will be requested to take a mild laxative of their choice the night before the exam, and not to eat for 2-4 hours prior to the scan. To facilitate this, that patient's exam will be booked prior to lunch. Prior to the exam, the patient will be asked to empty their bladder and 40 mg of Buscopan will be administered to the patient (i.m. of i.v.) to reduce peristalsis, the presence of which degrades the quality of NMR scans. The patient will lie on a board designed to fit on the MR scanner patient bed and that holds one of the elements of the dual element phased array radiofrequency (RF) coil in place. The patient will be positioned such that the prostate is within the coil's field of view (preferably along its central axis); that is, the patient will lie on one element of the coil and the other element will be placed on top of the patients abdomen. An abdominal restraint will be placed around the patients abdomen to reduce breathing effects. After the patient has been centered in the magnet, MRI (Magnetic Resonance Imaging) images will be acquired to identify the tumor location. The positioning of the MRS voxel with the prostate will be carefully determined with the aid of a radiation oncologist. Preparation scans for the spectroscopy acquisition will be carried out prior to applying a PRESS (Point RESolved Spectroscopy) sequence that will be employed to obtain a proton (1H) spectrum of the prostate. The entire scan duration from preparation till completion will be approximately 30 minutes (5 minutes for patient positioning, 10 minutes for imaging and voxel placement, 5 minutes for spectroscope sequence preparation scans, and 10 minutes for spectrum acquisition). Following scan completion, the patient will have about 150 mL of Barium solution administered to the rectum. After standing for 3-4 minutes, the patient will like back on the NMR scanner bed and the same NMR procedure will be repeated again. The spectra acquired without and with the presence of Barium solution in the rectum will be compared to see if the latter situation is indeed advantageous.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years
  • Localized prostate cancer patients
  • Signed informed consent form

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
A Magnetic Resonance Spectroscopy (MRS)study of a patient's prostate will be conducted with the 3 Tesla Philips Intera Nuclear Magnetic Resonance (NMR) scanner before and after filling the rectum with barium. Scan duration from Preparation to Completion will be approximately 30 minutes. The spectra will be acquired without and with the presence of Barium solution to compare to see if the latter is advantageous.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Imaging study to determine quality spectra on 3T MR
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Nadeem Pervez, MD, FRCPC, AHS Cancer Control Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

June 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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