Angiogenesis in Early Breast Cancer for Prognosis Prediction

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: Breast Lesions
• Intervention / Treatment: Procedure: magnetic resonance imaging

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

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.	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	at completion of enrollment

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

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