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Using Magnetic Resonance Spectroscopy With MRI to Non-invasively Determine Breast Cancer Extent of Disease

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Spectroscopy
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer Staging

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with recent (within 60 days) invasive breast cancer. No previous ipsilateral axillary surgery. Exclusion Criteria: 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.

Sites / Locations

  • Mammography Clinic - UNC Hospitals

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2006
Last Updated
April 27, 2012
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00312637
Brief Title
Using Magnetic Resonance Spectroscopy With MRI to Non-invasively Determine Breast Cancer Extent of Disease
Official Title
High-Resolution Axillary MRI With Magnetic Resonance Spectroscopy as a Non-Invasive Test for Determining Pathologic Lymph Node Status in Patients With Invasive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding.
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Breast cancer is the second leading cause of death in women. The spread of cancer from the breast to the lymph nodes is a significant factor in determining breast cancer survival. Currently, surgical procedures are performed to determine lymph node involvement. Full axillary lymph node dissection has a high morbidity associated with the procedure. While sentinel lymphadenectomy avoids a full axillary dissection in clinically negative axilla in untreated patients, it has been reported to have a false negative rate of less than 10%. Others have reported higher false negative rates after neoadjuvant chemotherapy. For those reasons, there is considerable interest in non-invasive methods that may allow staging of the axilla. Magnetic resonance imaging (MRI) of the breast with contrast-enhancement is increasingly being used in breast cancer patients to determine the size of the tumor and its extent. A few reports from Europe have been published regarding its use in evaluating axillary lymph node metastases preoperatively, and the results appear promising. Kvistad et al. demonstrated lymph node metastases using dynamic contrast-enhanced MRI, in which the study had a sensitivity of 83%, a specificity of 90%, and an accuracy of 88%. Luciani et al, suggest that lymph nodes with a large size, irregular contours, round hila, high-signal intensity on T2 sequences, and those with marked enhancement are associated with malignancy. Magnetic resonance imaging with spectroscopy (MRS) has been used in clinical practice for evaluation of brain tumors as a method for noninvasive detection of tumor metabolism. More recently, it has been used on other soft-tissue tumors, including breast. Like other soft-tissue tumors, breast cancers have increased levels of the amino acid choline. In several studies, the sensitivity and specificity of MRS for detecting breast cancer ranged from 73%-92% and 71%-93%, respectively. No known MRS data has been published regarding axillary lymph node involvement in patients with breast cancer. It is postulated that the choline peak should be elevated in lymph nodes with metastatic breast cancer. This is an observational study. All eligible patients who give informed consent will complete a MRI/MRS screening questionnaire and if there are no contraindications will undergo MRI/MRS imaging prior to their clinically indicated sentinel lymphadenectomy which may be followed by axillary dissection to be determined by surgeon during the course of surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer Staging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Spectroscopy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with recent (within 60 days) invasive breast cancer. No previous ipsilateral axillary surgery. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherie M Kuzmiak, D.O.
Organizational Affiliation
Department of Radiology, University of North Carolina at Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mammography Clinic - UNC Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Using Magnetic Resonance Spectroscopy With MRI to Non-invasively Determine Breast Cancer Extent of Disease

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