NCT00310479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2006

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 25, 2016

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

April 3, 2006

Last Update Submit

February 24, 2016

Conditions

Prostate Cancer

Keywords

Magnetic Resonance Imagingprostate cancer imaging3T MRSfunctional imaging

Outcome Measures

Primary Outcomes (1)

  • characteristic metabolic pattern of prostate cancer at 3Tesla

Secondary Outcomes (2)

  • specificity, accuracy, NPV

  • PPV of MRS in the detection of prostate cancer

Interventions

Magnetic Resonance Spectroscopy (3Tesla)DEVICE

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Nonbiopsied lesion
  • Intermediate or high risk prostate cancer
  • Unfit for surgery
  • Contraindication to MR scanning (i.e. pacemaker, aneurysm clips, claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Matthew Parliament, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 4, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 25, 2016

Record last verified: 2012-03

Locations

CA(1)