NCT00312637

Brief Summary

The purpose of this study is to evaluate whether high-resolution magnetic resonance imaging of the axilla with spectroscopy can identify nodal features suggestive of metastatic involvement in patients diagnosed with invasive breast cancer. This may enable us to define a select group of patients for whom axillary lymph node dissection could be avoided.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2005

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

3 years

First QC Date

April 6, 2006

Last Update Submit

April 27, 2012

Conditions

Breast Cancer

Keywords

Breast Cancer Staging

Interventions

Magnetic Resonance SpectroscopyPROCEDURE

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with recent (within 60 days) invasive breast cancer.
  • No previous ipsilateral axillary surgery.

You may not qualify if:

  • Patients diagnosed with in situ disease.
  • Patients with previous ipsilateral axillary surgery.
  • Patients with MRI/MRA contraindications such as a cardiac pacemaker, an aneurysm clip, cochlear implants, and metal in the eyes.
  • Patients who have had a moderate or severe contrast reaction to intravenous gadolinium-DTPA.
  • Patients who are clinically not stable.
  • Patients who cannot give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mammography Clinic - UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Cherie M Kuzmiak, D.O.

    Department of Radiology, University of North Carolina at Chapel Hill

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

April 6, 2006

First Posted

April 10, 2006

Study Start

March 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations

US(1)