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High Resolution 3D Diffusion-weighted Breast MRI


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Carcinoma Breast Stage IV

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Trial Information

High Resolution 3D Diffusion-weighted Breast MRI


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Sensitivity of the new MRI method

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Bruce Lewis Daniel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

SU-11152010-7211

NCT ID:

NCT01315106

Start Date:

March 2011

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Carcinoma Breast Stage IV
  • Breast Neoplasms
  • Carcinoma

Name

Location

Stanford University School of MedicineStanford, California  94305-5317