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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-BRE-0588 | |||
| VU-VICC-IRB-051230 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants without breast cancer | Active Comparator |
| |
| Participants with breast cancer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diffusion-weighted magnetic resonance imaging | Procedure | A scan will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. Time frames begin at study entry (healthy volunteers) , pre-surgical and pre- and post-chemotherapy (breast cancer patients) | on-study date and at 6 months, up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings | Biochemical data from advanced MRIs are compared and contrasted with findings from patients' clinical, chemotherapeutic, and radiologic treatments for breast cancer. | at 6 months |
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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
* 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:
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| Name | Affiliation | Role |
|---|---|---|
| A. Bapsi Chakravarthy, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17222711 | Result | 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. | |
| 23157877 | Derived | 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. |
| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| dynamic contrast-enhanced magnetic resonance imaging | Procedure | A scan will be performed. |
|
| magnetic resonance spectroscopic imaging | Procedure | A scan will be performed. |
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| Establishment of an imaging data bank |
Results of advanced MRI imaging methods for subjects assessed after completion of all MRI procedures |
| at 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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