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Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Magnetic Resonance Spectroscopy (3Tesla)
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Magnetic Resonance Imaging, prostate cancer imaging, 3T MRS, functional imaging

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically verified prostate cancer Patient has opted for surgery Low risk prostate cancer PSA <1 0, Gleason < 7, Stage < T2b No contraindication to MR scanning No prior history of malignancy Fit for surgery Exclusion Criteria: Nonbiopsied lesion Intermediate or high risk prostate cancer Unfit for surgery Contraindication to MR scanning (i.e. pacemaker, aneurysm clips, claustrophobia)

Sites / Locations

  • Cross Cancer Institute

Outcomes

Primary Outcome Measures

characteristic metabolic pattern of prostate cancer at 3Tesla

Secondary Outcome Measures

specificity, accuracy, NPV
PPV of MRS in the detection of prostate cancer

Full Information

First Posted
April 3, 2006
Last Updated
February 24, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00310479
Brief Title
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer
Official Title
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We seek to develop an advanced imaging approach to identifying and localizing prostate cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do this and we will endeavor to prove this by having patients with prostate cancer pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery, the microscopic locations of cancer will be compared with the pre-operative images to assess how well the imaging technique succeeds.
Detailed Description
The proposed research is enormously relevant to the clinical understanding of early prostate cancer. We propose to test to see whether characteristic patterns of invivo 3T MRSI associated metabolites can be identified in correlation with clinically active tumor reserved on histopathologic analysis of resected specimens. We also plan to demonstrate that 3T MR spectra of prostate cancer will allow for more detailed metabolic assessment with higher sensitivity, specificity and accuracy and publish results established from MR spectra using 1.5T MR units. Functional imaging (eg. molecular imaging such as this) is felt to be the clinical wave of the future for cancer imaging, and if successful, will assume a very major role in the detection, assessment, treatment planning and delivery of drugs, radiation, heat and novel therapeutics in the fight against prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Magnetic Resonance Imaging, prostate cancer imaging, 3T MRS, functional imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Spectroscopy (3Tesla)
Primary Outcome Measure Information:
Title
characteristic metabolic pattern of prostate cancer at 3Tesla
Secondary Outcome Measure Information:
Title
specificity, accuracy, NPV
Title
PPV of MRS in the detection of prostate cancer

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically verified prostate cancer Patient has opted for surgery Low risk prostate cancer PSA <1 0, Gleason < 7, Stage < T2b No contraindication to MR scanning No prior history of malignancy Fit for surgery Exclusion Criteria: Nonbiopsied lesion Intermediate or high risk prostate cancer Unfit for surgery Contraindication to MR scanning (i.e. pacemaker, aneurysm clips, claustrophobia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Parliament, MD
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

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