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Angiogenesis in Early Breast Cancer for Prognosis Prediction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599105
First Posted: January 23, 2008
Last Update Posted: November 19, 2010
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.
Information provided by:
University of California, Irvine
  Purpose
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 Intervention
Breast Lesions Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Angiogenesis in Early Breast Cancer for Prognosis Prediction

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

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

Estimated Enrollment: 700
Study Start Date: November 2000
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: magnetic resonance imaging
    MRI contrast agent, 0.1 mmol/kg
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00599105


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

Responsible Party: Min-Ying Su, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00599105     History of Changes
Other Study ID Numbers: UCI-HS-2000-1141
NIH-CA90437
CBCRP-9WB-0020
First Submitted: January 10, 2008
First Posted: January 23, 2008
Last Update Posted: November 19, 2010
Last Verified: November 2010