Angiogenesis in Early Breast Cancer for Prognosis Prediction | NCT00599105

Studies
Angiogenesis in Early Breast Cancer for Prognosis Prediction

NCT00599105

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 19, 2010Estimated

Enrollment

700Estimated

Phase

Not Applicable

Conditions

Breast 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

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2000

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 22, 2008

First Posted Date

Jan 23, 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

Nov 17, 2010

Last Update Posted Date

Nov 19, 2010Estimated

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

This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.

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

700Estimated

Name	Type	Description	Arm Group Labels	Other Names
magnetic resonance imaging	Procedure	MRI contrast agent, 0.1 mmol/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome.		5 years from completion of enrollment

Secondary Outcomes

Measure	Description	Time Frame
To investigate whether angiogenesis of breast cancer is associated wit lymph node status		at completion of enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with a breast mass highly suspicious for malignancy from clinical, mammographic or sonographic examination.
The study has been explained to the patient when she is scheduled for surgery.
Healthy normal volunteers for imaging protocol optimization.

Exclusion Criteria:

Pregnancy
Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
Patients with implanted prosthetic heart valves,
Patients with pacemakers, neuro-stimulation devices,
A breast mass with features of benign tumor
The patients unwilling to participate in the study or fail to sign the consent form

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

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
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
NIH-CA90437
CBCRP-9WB-0020