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


N/A
N/A
N/A
Not Enrolling
Female
Breast Neoplasms

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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.


Inclusion Criteria:



1. A woman with a known or with radiographic evidence of a breast neoplasm metastatic to
the brain, who has agreed to participate in the protocol "Analysis of Brain
Metastasis in Patients with Breast Cancer, with and without over-expression of
HER-2," and who will undergo a pre-operative MR scan immediately before surgery.

2. Medically-indicated (diagnostic and/or therapeutic) brain tumor resection.

3. Informed consent from female patient, age 18 or older. In general, patients less
than 18 years of age rarely have breast cancer metastatic to the brain.

Exclusion Criteria:

1. Inability to provide informed consent prior to surgery.

2. Medical conditions that cannot be corrected prior to surgery that would be standard
contraindications for craniotomy (brain tumor patients).

3. Conditions that preclude MR imaging of the brain (Patients with pacemakers, cerebral
aneurysm clips, shrapnel injury or implantable electronic devices) or known allergy
to gadolinium.

4. Men

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

040003

NCT ID:

NCT00071357

Start Date:

October 2003

Completion Date:

October 2004

Related Keywords:

  • Breast Neoplasms
  • Microarray
  • Herceptin
  • Trastuzumab
  • Carcinoma
  • Proteomics
  • Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic Breast Tumor
  • Breast Neoplasms
  • Neoplasms

Name

Location

National Institute of Neurological Disorders and Stroke (NINDS)Bethesda, Maryland  20892