NCT00756392

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 18, 2016

Status Verified

June 1, 2014

Enrollment Period

5.5 years

First QC Date

September 18, 2008

Last Update Submit

July 14, 2016

Conditions

Prostate Cancer

Keywords

3T MR SpectroscopyProstate Imaging

Outcome Measures

Primary Outcomes (1)

  • Imaging study to determine quality spectra on 3T MR

    1 Year

Study Arms (1)

1

OTHER
Procedure: 3T MR Spectroscopy

Interventions

3T MR SpectroscopyPROCEDURE

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Nadeem Pervez, MD, FRCPC

    AHS Cancer Control Alberta

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 22, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 18, 2016

Record last verified: 2014-06

Locations

CA(1)