Angiogenesis in Early Breast Cancer for Prognosis Prediction

This study has been completed.

First Received on January 10, 2008. Last Updated on November 17, 2010 History of Changes

Sponsor:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00599105

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

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:

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 February 09, 2012