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The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.
See brief summary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEM Breast Biopsy | Experimental | All patients underwent PEM biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEM Breast Biopsy | Procedure | Breast biopsy using PEM guidance and Stereo Navigator software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | At time of biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary C Mahoney, MD | Univeristy of Cincinnati | Principal Investigator |
| Amy Argus, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Hospital, The Barrett Center | Cincinnnati | Ohio | 45219 | United States |
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Recruited from 02/2010 to 06/2011 from University of Cincinnati Medical Center, Radiology Department, Breast Imaging.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEM Breast Biopsy | PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Women 25 or older
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary | Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Women 25 years of age or older with a highly suspicious breast mass recommended to biopsy. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | Posted | Number | Breast Lesions | At time of biopsy |
|
|
One year and four months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEM Breast Biopsy | PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Mahoney, MD | University of Cincinnati Medical Center | 513-584-4396 | mary.mahoney@uchealth.com |
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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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| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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| D017437 |
| Skin and Connective Tissue Diseases |