Purpose

RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment. PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

Women who satisfy 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) - Subjects who have vascular access ports or other implanted devices rated as anything other than "Safe" or "Conditional 6"

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Participants without breast cancer
  • Procedure: diffusion-weighted magnetic resonance imaging
    A scan will be performed.
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
    A scan will be performed.
  • Procedure: magnetic resonance spectroscopic imaging
    A scan will be performed.
Experimental
Participants with breast cancer
  • Procedure: diffusion-weighted magnetic resonance imaging
    A scan will be performed.
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
    A scan will be performed.
  • Procedure: magnetic resonance spectroscopic imaging
    A scan will be performed.

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232-6838
Contact:
Clinical Trials Office - Vanderbilt-Ingram Cancer Center
800-811-8480

More Details

Status
Recruiting
Sponsor
Vanderbilt-Ingram Cancer Center

Study Contact

VICC Clinical Trials Information Program
800-811-8480

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.