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N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information


Inclusion Criteria:



- Subjects must have histologically proven breast cancer

- Subjects are being considered for preoperative chemotherapy

- Subjects must be ≥ 18 years old.

Exclusion Criteria:

- Children will be excluded from this study.

- Pregnant women and women who are breast feeding will be excluded from this study.
(The "PET Procedure Screening Form" will be used to identify and exclude subjects who
are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be
performed for women of child bearing potential)

- Patients who are acutely ill who are deemed by their treating physician as not
suitable candidates for this study

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Changes in the standard uptake value (SUV) and Gadolinium contrast parameters will be used as a predictor of response then correlated to complete pathologic response measured at the time of definitive surgery.

Outcome Time Frame:

Prior to chemotherapy, within 7-14 days following the start of chemotherapy and immediately prior to surgery.

Safety Issue:

No

Principal Investigator

A. Bapsi Chakravarthy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

VICC BRE 09108

NCT ID:

NCT01222416

Start Date:

October 2010

Completion Date:

December 2019

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838