Imaging of Prostate Cancer Using Two-dimensional MR Spect... | NCT00611065

Studies
Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging

NCT00611065

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Jul 20, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Prostate Lesions

Interventions

magnetic resonance imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

There is no funding to proceed.

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jun 2009Estimated

Completion Date

Not provided

First Submitted Date

Jan 12, 2008

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Feb 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2018

Last Update Posted Date

Jul 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
magnetic resonance imaging	Device	MR contrast agent (0.1 mmol/kg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min-Ying Su, PhD	University of California, Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Functional Onco-Imaging, University of California		Irvine	California	92697	United States

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided