Angiogenesis in Early Breast Cancer for Prognosis Prediction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599105
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : November 19, 2010
Information provided by:
University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Breast Lesions Procedure: magnetic resonance imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Angiogenesis in Early Breast Cancer for Prognosis Prediction
Study Start Date : November 2000
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: magnetic resonance imaging
    MRI contrast agent, 0.1 mmol/kg

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

Secondary Outcome Measures :
  1. To investigate whether angiogenesis of breast cancer is associated wit lymph node status [ Time Frame: at completion of enrollment ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599105

United States, California
Center for Functional Onco-Imaging, University of California
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine

Responsible Party: Min-Ying Su, University of California, Irvine Identifier: NCT00599105     History of Changes
Other Study ID Numbers: UCI-HS-2000-1141
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010