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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local staging patients | Experimental | Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard. |
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| Neoadjuvant chemotherapy patients | Experimental | Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron Emission Tomography (PET) | Procedure |
| ||
| Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) |
| Measure | Description | Time Frame |
|---|---|---|
| assess the diagnostic accuracy | Accuracy of standardized uptake values will be analyzed by receiver operating characteristic (ROC) curves. ROC curves will be constructed separately for FACBC PET, FACBC PEM and MR. The area under the curve will be used as a summary measure and compared using the standard nonparametric test [20]. We will also consider dichotomizing the uptake and present accuracy using sensitivity, specificity and predictive values. Dichotomized values will be compared using the McNemar test. | 2 years |
| ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy | Patients with locally advanced IDC or ILC, requiring neoadjuvant therapy prior to definitive surgery, will undergo FACBC PET and PEM both before chemotherapy and after. Following definitive breast surgery, pathologic specimens will be analyzed to determine if FACBC imaging can predict pathologic treatment response. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Ulaner, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27856630 | Derived | Ulaner GA, Goldman DA, Corben A, Lyashchenko SK, Gonen M, Lewis JS, Dickler M. Prospective Clinical Trial of 18F-Fluciclovine PET/CT for Determining the Response to Neoadjuvant Therapy in Invasive Ductal and Invasive Lobular Breast Cancers. J Nucl Med. 2017 Jul;58(7):1037-1042. doi: 10.2967/jnumed.116.183335. Epub 2016 Nov 17. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Drug |
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| Positron emission mammography (PEM) When available | Procedure |
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| MR | Procedure |
|
| 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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