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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

25 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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

- Patients who are clinically not stable.

- Patients who cannot give consent.

Type of Study:


Study Design:

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

Principal Investigator

Cherie M Kuzmiak, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiology, University of North Carolina at Chapel Hill


United States: Food and Drug Administration

Study ID:




Start Date:

March 2005

Completion Date:

March 2008

Related Keywords:

  • Breast Cancer
  • Breast Cancer Staging
  • Breast Neoplasms



Mammography Clinic - UNC Hospitals Chapel Hill, North Carolina  27514