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
  Purpose

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.


Condition Intervention
Prostate Cancer
Device: Magnetic Resonance Spectroscopy (3Tesla)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

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

Enrollment: 16
Study Start Date: June 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00310479

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Matthew Parliament, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00310479     History of Changes
Other Study ID Numbers: GU-6-0062 / 22281
Study First Received: April 3, 2006
Last Updated: March 19, 2012
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Magnetic Resonance Imaging
prostate cancer imaging
3T MRS
functional imaging

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 10, 2014