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

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ClinicalTrials.gov Identifier: NCT00310479
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : February 25, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment
Prostate Cancer Device: Magnetic Resonance Spectroscopy (3Tesla)

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  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer
Study Start Date : June 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. characteristic metabolic pattern of prostate cancer at 3Tesla

Secondary Outcome Measures :
  1. specificity, accuracy, NPV
  2. PPV of MRS in the detection of prostate cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310479

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

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00310479     History of Changes
Other Study ID Numbers: GU-6-0062 / 22281
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: March 2012

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

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