Clinical trial NCT00474604: Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
Official title: MRI Evaluation of Breast Tumor Growth and Treatment Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-17
Enrollment: 209
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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"

Primary outcomes:
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
timeFrame: on-study date and at 6 months, up to 4 years
Secondary outcomes:
measure: Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings
timeFrame: at 6 months
measure: Establishment of an imaging data bank
timeFrame: at 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: A. Bapsi Chakravarthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yankeelov TE, Lepage M, Chakravarthy A, Broome EE, Niermann KJ, Kelley MC, Meszoely I, Mayer IA, Herman CR, McManus K, Price RR, Gore JC. Integration of quantitative DCE-MRI and ADC mapping to monitor treatment response in human breast cancer: initial results. Magn Reson Imaging. 2007 Jan;25(1):1-13. doi: 10.1016/j.mri.2006.09.006. Epub 2006 Nov 21.
citation: Li X, Abramson RG, Arlinghaus LR, Chakravarthy AB, Abramson V, Mayer I, Farley J, Delbeke D, Yankeelov TE. An algorithm for longitudinal registration of PET/CT images acquired during neoadjuvant chemotherapy in breast cancer: preliminary results. EJNMMI Res. 2012 Nov 16;2(1):62. doi: 10.1186/2191-219X-2-62.