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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02258 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
| U.S. Army Medical Research Acquisition Activity | FED |
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This trial studies how well an imaging technique called magnetic resonance (MR) spectroscopic imaging works in identifying breast cancer in women with benign or suspicious areas in the breast. Magnetic resonance imaging (MRI) is a diagnostic tool used to investigate the location of tumors in different organs. Since radiological pictures do not have sufficient information for tumor grades, invasive procedure such as biopsy is performed on patients with breast cancers for diagnosis. Breast tissue contains water, fat, and chemicals known as metabolites. MR spectroscopic imaging may help to characterize the various breast metabolite steady state levels and identify the differences between necrosis and tumor recurrence, which is difficult using radiological procedures such as MRI.
PRIMARY OBJECTIVES:
I. Non-uniform undersampling schemes (NUS) will be combined with 5-dimensional (5D) echo-planar imaging based correlated spectroscopic imaging (EP-COSI) sequence.
II. Group sparsity (GS)-based compressed-sensing (CS) reconstruction schemes will be developed for accelerated acquisition and optimized to reconstruct the NUS EP-COSI data with better reliability.
III. Alterations in metabolite and lipid levels will be correlated with apparent diffusion coefficient (ADC) changes in breast cancer patients compared to healthy women which will improve the diagnostic accuracy.
OUTLINE:
Participants undergo diffusion weighted imaging (DWI)-MRI over 15 minutes and MR spectroscopic imaging over 45 minutes.
After completion of study, participants are followed up for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (DWI, magnetic resonance spectroscopic imaging) | Experimental | Participants undergo DWI over 15 minutes and MR spectroscopic imaging over 45 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Weighted Imaging | Procedure | Undergo DWI-MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Apparent diffusion coefficient (ADC) maps | ADC maps will be calculated from diffusion weighted (DW) images by using linear regression of logarithmic intensities by using software for combinations of two, three, four, and five DW images with different b values. ADC maps will also be calculated for the remaining combinations of up to 10 evenly distributed b values. In total, 501 value combinations will be automatically processed and analyzed. | At the time of imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Thomas | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin 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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| Magnetic Resonance Spectroscopic Imaging | Procedure | Undergo MR spectroscopic imaging |
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| D017437 |
| Skin and Connective Tissue Diseases |