MRI Evaluation of Breast Tumor Growth and Treatment Response
18 Years
N/A
Female
Breast Cancer
Trial Information
MRI Evaluation of Breast Tumor Growth and Treatment Response
OBJECTIVES:
- Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging
methods (i.e., dynamic contrast-enhanced MRI [DCE-MRI], diffusion-weighted MRI
[DW-MRI], and magnetic resonance spectroscopy [MRS]) to characterize breast tumors in
women with known or suspected breast cancer.
- Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer
using these methods.
- Correlate biochemical information obtained from magnetic resonance analysis with
clinical, radiologic, and pathologic findings in these patients.
- Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS
findings in these patients and in healthy participants.
OUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for
breast imaging for the following subjects:
- Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks.
- Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast
MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant
chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive
surgery.
Clinical information, including radiologic and pathologic data, on all patients is collected
for inclusion in the imaging data bank.
After completion of the study, patients and healthy participants are followed periodically.
Inclusion Criteria
Inclusion criteria:
Women who satisfy all of the following conditions are the only subjects who will be
eligible for this study:
- Normal volunteers
- Subjects with known or suspected breast disease
- Subjects must have signed an approved consent form.
- Subjects must be ≥ 18 years old.
- The protocol nurse will check with the patient that there is no h/o kidney disease
- Normal creatinine and estimated GFR* within 30 days under the following circumstances
- Had abnormal creatinine in the last 60 days
- Are over 60 years of age
- Has received chemotherapy within the past 30 days
- Has diabetes, HIV, renal disease or hx of renal cancer
- * GFR will be calculated using:
http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
- Patients with an eGFR>90ml/min reported within 30 days, and who have not had
intervening chemotherapy or other treatment or condition that might deteriorate renal
function, may receive any gadolinium agent.
Exclusion Criteria:
- Children will be excluded from this study.
- Pregnant women and women who are breast feeding will be excluded from this study.
(The Vanderbilt University Medical Center radiology "MRI 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 each pre-menopausal
subject.)
- Subjects found to have any constitutionally present non-MR compatible ferromagnetic
materials will be excluded from this study.
- Patients who are acutely ill who are deemed by their treating physician as not
suitable candidates for this study
- Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response
Outcome Description:
Quantitative, multi-parametric MRI imaging methods include Dynamic Contrast MRI, Diffusion Weighted MRI, and Magnetic Resonance Spectroscopy. Patients will include healthy female volunteers and women diagnosed with breast cancer
Outcome Time Frame:
at study entry (healthy volunteers), pre-surgical and pre- and post-chemotherapy (breast cancer patients)
Safety Issue:
No
Principal Investigator
A. Bapsi Chakravarthy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
VICC BRE 0588
NCT ID:
NCT00474604
Start Date:
March 2006
Completion Date:
December 2015
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee 37064 |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee 37064 |
