Angiogenesis in Early Breast Cancer for Prognosis Prediction - Tabular View

Tracking Information

First Received Date ^ICMJE

January 10, 2008

Last Updated Date

November 5, 2009

Start Date ^ICMJE

November 2000

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome. [ Time Frame: 5 years from completion of enrollment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00599105 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To investigate whether angiogenesis of breast cancer is associated wit lymph node status [ Time Frame: at completion of enrollment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Angiogenesis in Early Breast Cancer for Prognosis Prediction

Official Title ^ICMJE

Angiogenesis in Early Breast Cancer for Prognosis Prediction

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment

Condition ^ICMJE

Breast Lesions

Intervention ^ICMJE

Procedure: magnetic resonance imaging

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

700

Completion Date

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Min-Ying Su, PhD

949-824-6001

msu@uci.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00599105

Responsible Party

Min-Ying Su, University of California, Irvine

Study ID Numbers ^ICMJE

UCI-HS-2000-1141, NIH-CA90437, CBCRP-9WB-0020

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

University of California, Irvine

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP