Angiogenesis in Early Breast Cancer for Prognosis Prediction

Breast Lesions Clinical Trial

Official title:

Angiogenesis in Early Breast Cancer for Prognosis Prediction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599105
• Other study ID #: UCI-HS-2000-1141
• Secondary ID: NIH-CA90437CBCRP
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: November 17, 2010
• Start date: November 2000
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Lesions

Intervention

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

Locations

Country	Name	City	State
United States	Center for Functional Onco-Imaging, University of California	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome.		5 years from completion of enrollment	No
Secondary	To investigate whether angiogenesis of breast cancer is associated wit lymph node status		at completion of enrollment	No