High Resolution 3D Diffusion-weighted Breast MRI



Status:Suspended
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/19/2018
Start Date:March 2011
End Date:December 2019

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The purpose of this study is to determine how well a new MRI technique called "High
resolution 3D diffusion-weighted breast MRI" detects breast cancer.

The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI
method for breast cancer detection. The study design is a single arm observational study. The
new technique will be added on to the standard sequences that a women undergoes during a
breast MRI. The resulting images will be compared with her standard breast MRI images, and
with results of subsequent pathology.

Inclusion Criteria:1. Patient scheduled for contrast-enhanced breast MRI to image possible
breast cancer.

2. Female

3. Age >18

Exclusion Criteria:1. Lactation

2. Pregnancy

3. Patient undergoing chemotherapy. These patients are excluded because chemotherapy
changes the biology of breast cancers. Since the ultimate objective of the research is to
develop a new imaging method for breast MRI screening (detection of previously unknown
tumors), results in treated tumors would not be relevant. Including treated tumors could
yield a misleading assessment of the performance of the new method since treated tumors
have different imaging characteristics than de novo tumors.

4. Patient scheduled for pre-operative chemotherapy. These patients are excluded if they
are going to be treated only on the basis of fine needle aspiration. The project seeks to
correlate all tumors detected with standard histopathology of their untreated neoplasm.
This exclusion criteria will be very unusual because most patients planning neoadjuvant
chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate
histopathologic proof necessary for enrollment.
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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mi
from
Stanford, CA
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