Trial Information

Use of Dynamic Contrast-Enhanced Magnetic Resonance Imaging to Assess Tumor-Associated Vasculature in Patients With Metastatic Breast Cancer

Introduction: Metastasis of epithelial tumors, such as breast cancer, to the brain is a
common problem, with significant consequences with respect to neurological dysfunction and
shortening of survival. One necessary step for tumor growth anywhere is the development of
a blood supply.

Objectives: We seek to compare a new, non-invasive method of assessing neo-vascularization,
dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) with a
gold-standard-microvessel counts-and to see if we can identify gene expression patterns
within the tumor itself, from areas shown as low flow versus those that are high-flow on
DCE-MRI if there are features within the tumor itself that influence the degree of
neovascularization. This prospective study will only be utilized in conjunction the
protocol entitled "Analysis of Brain Metastasis in Patients with Breast Cancer, with and
without over-expression of HER-2" that is evaluating breast tumors metastatic to the brain.

Study Population: A series of women with breast cancer metastatic to the brain who do
(n=39) or do not (n=39) over-express the growth factor receptor, HER-2, entered into a
prospective trial in which pre-operative MRI imaging is performed as a matter of standard
medical practice. At the time of this pre-operative MR, we propose to add one additional,
10-minute MR series, a dynamic, contrast-enhance image to assess the extent of blood flow
through various aspects of the tumor.

Anticipated Risks and Benefits: There are no obvious risks or benefits to patients who
participate in this protocol. It is felt that this study involves no more than minimal risk.

Estimation of Outcome/Potential Meaning: We believe that this protocol will help us
identify tumors with higher or lower degrees of neovascularization as well as identify
tumor-intrinsic factors via microarrays performed on microdissected tissues. This is
becoming an important issues as cytostatic treatments, such as anti-angiogenic agents, enter
the clinical area, and are used singly or in combination with cytotoxic therapies.