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Prostate CancerNCT00756392

Magnetic Resonance (MR) Spectroscopy in Localized Prostate Cancer

A study testing 3T MR Spectroscopy in people with Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
3T MR Spectroscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
Oct 2008to Apr 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
3T MR Spectroscopy
Keywords
3T MR Spectroscopy, Prostate Imaging
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3T MR SpectroscopyProcedure or surgery

    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.

Study groups in NCT00756392
Study groupRoleWhat they receive
1OtherNot described
Receives: Procedure: 3T MR Spectroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Imaging study to determine quality spectra on 3T MR

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00756392
Sponsor's protocol ID
GU-24315
Status last verified
Jun 2014
First submitted
18 Sep 2008
Last updated
18 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing 3T MR Spectroscopy in people with Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Imaging study to determine quality spectra on 3T MR (time frame: 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.

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