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Angiogenesis in Early Breast Cancer for Prognosis Prediction

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00599105
First received: January 10, 2008
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Angiogenesis in Early Breast Cancer for Prognosis Prediction

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 10, 2008
Last Updated: November 17, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013