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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00310479
First received: April 3, 2006
Last updated: March 19, 2012
Last verified: March 2012

April 3, 2006
March 19, 2012
June 2006
March 2008   (final data collection date for primary outcome measure)
characteristic metabolic pattern of prostate cancer at 3Tesla
Same as current
Complete list of historical versions of study NCT00310479 on ClinicalTrials.gov Archive Site
  • specificity, accuracy, NPV
  • PPV of MRS in the detection of prostate cancer
Same as current
Not Provided
Not Provided
 
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
Device: Magnetic Resonance Spectroscopy (3Tesla)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2008
March 2008   (final data collection date for primary outcome measure)

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)
Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00310479
GU-6-0062 / 22281
No
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Not Provided
Principal Investigator: Matthew Parliament, MD AHS Cancer Control Alberta
AHS Cancer Control Alberta
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP