- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310479
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer
February 24, 2016 updated by: AHS Cancer Control Alberta
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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)
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
characteristic metabolic pattern of prostate cancer at 3Tesla
|
Secondary Outcome Measures
Outcome Measure |
---|
specificity, accuracy, NPV
|
PPV of MRS in the detection of prostate cancer
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Parliament, MD, 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
June 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
April 3, 2006
First Submitted That Met QC Criteria
April 3, 2006
First Posted (Estimate)
April 4, 2006
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 24, 2016
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GU-6-0062 / 22281
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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