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Clinical Trials/NCT00310479
NCT00310479CompletedNot Applicable

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

AHS Cancer Control Alberta1 site in 1 country16 target enrollmentStarted: June 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
characteristic metabolic pattern of prostate cancer at 3Tesla

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

characteristic metabolic pattern of prostate cancer at 3Tesla

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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