Angiogenesis in Early Breast Cancer for Prognosis Prediction

November 17, 2010 updated by: University of California, Irvine
This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Center for Functional Onco-Imaging, University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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