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High Resolution 3D Diffusion-weighted Breast MRI
Conditions
Breast Cancer - Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Magnetic Resonance Image Scanner
Type: Device
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
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.
Location
Stanford University School of Medicine
Stanford, California, United States
Status: Recruiting
Contact: Sumita Sood - 650-723-0618 - ssood@stanford.edu
Start Date
March 2011
Completion Date
June 2016
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page