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Subcontract PI left institution.
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| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
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The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.
70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic accuracy with MRI alone | No Intervention | The MRI of the breast lesion will be examined. Measures of performance accuracy will be evaluated, including diagnostic sensitivity (true positives divided by true positives and false negatives), diagnostic specificity (true negatives divided by true negatives and false positives), and diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments. | |
| Diagnostic accuracy with MRI + PEM image | Experimental | The combined PEM/MRI image will be examined. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI + PEM image | Device | Effect of positron emission mammography on diagnostic accuracy |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments) | Patients with benign disease on biopsy may be followed for up to 2 years after imaging | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irving Weinberg, MD PhD | Weinberg Medical Physics LLC | Principal Investigator |
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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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| D017437 |
| Skin and Connective Tissue Diseases |