Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
NCT ID: NCT00474604
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
209 participants
INTERVENTIONAL
2006-03-31
2023-04-25
Brief Summary
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PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.
Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Participants without breast cancer
diffusion-weighted magnetic resonance imaging
A scan will be performed.
dynamic contrast-enhanced magnetic resonance imaging
A scan will be performed.
magnetic resonance spectroscopic imaging
A scan will be performed.
Participants with breast cancer
diffusion-weighted magnetic resonance imaging
A scan will be performed.
dynamic contrast-enhanced magnetic resonance imaging
A scan will be performed.
magnetic resonance spectroscopic imaging
A scan will be performed.
Interventions
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diffusion-weighted magnetic resonance imaging
A scan will be performed.
dynamic contrast-enhanced magnetic resonance imaging
A scan will be performed.
magnetic resonance spectroscopic imaging
A scan will be performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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"
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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A Bapsi Chakravarthy, MD
Professor; Radiation Oncology
Principal Investigators
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A. Bapsi Chakravarthy, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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References
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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.
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.
Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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VU-VICC-BRE-0588
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-IRB-051230
Identifier Type: -
Identifier Source: secondary_id
VICC BRE 0588
Identifier Type: -
Identifier Source: org_study_id