NCT00611065

Brief Summary

The goal is to develop MR imaging techniques to improve delineation of cancer extent, and to improve differential diagnosis between prostate cancer and benign prostate hyperplasia or other benign diseases.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

June 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2008

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

January 12, 2008

Last Update Submit

July 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • To demonstrate that multi-voxel MR spectroscopy and diffusion tensor imaging can accurately diagnose prostate cancer and benign diseases, also to provide an accurate disease extent.

    at completion of the study

Interventions

MR contrast agent (0.1 mmol/kg)

Eligibility Criteria

Age21 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A male older than 21 years of age and under age of 80,
  • Either a normal healthy volunteer; a patient who has confirmed prostate cancer and decided to receive prostatectomy; or a patient who has persistent elevated PSA higher than 4.0 ng/ml, and with a prior benign biopsy scheduled to receive the second biopsy.

You may not qualify if:

  • Unwilling to give informed consent,
  • Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
  • Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
  • Have received orthodontic work involving ferromagnetic materials,
  • Claustrophobic,
  • Unable to lie down still for 60 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Functional Onco-Imaging, University of California

Irvine, California, 92697, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Min-Ying Su, PhD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

January 12, 2008

First Posted

February 8, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2009

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations