NCT00599105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

9.7 years

First QC Date

January 10, 2008

Last Update Submit

November 17, 2010

Conditions

Breast Lesions

Outcome Measures

Primary Outcomes (1)

  • To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome.

    5 years from completion of enrollment

Secondary Outcomes (1)

  • To investigate whether angiogenesis of breast cancer is associated wit lymph node status

    at completion of enrollment

Interventions

magnetic resonance imagingPROCEDURE

MRI contrast agent, 0.1 mmol/kg

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Functional Onco-Imaging, University of California

Irvine, California, 92697, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 23, 2008

Study Start

November 1, 2000

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

US(1)