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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310479
• Other study ID #: GU-6-0062 / 22281
• Status: Completed
• Phase: N/A
• First received: April 3, 2006
• Last updated: February 24, 2016
• Start date: June 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Magnetic Resonance Spectroscopy (3Tesla)

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	characteristic metabolic pattern of prostate cancer at 3Tesla
Secondary	specificity, accuracy, NPV
Secondary	PPV of MRS in the detection of prostate cancer