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Poor accrual
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The purpose of this study is:
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beast cancer subjects | Experimental | Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEM Flex Solo II PET Scanner | Device | Subjects will receive bilateral (both sides) breast and axillary PEM scans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Tumor Size | Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved. | 1-2 weeks post treatment onset |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirti Kulkarni, M.D. | The University of Chicago Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Beast Cancer Subjects | Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans. MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MRI scan | Device | Subjects will receive bilateral (both sides) breast and axillary MRI scans. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Beast Cancer Subjects | Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans. MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Reduction in Tumor Size | Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved. | This study has been terminated due to poor accrual. | Posted | Mean | Standard Deviation | mm | 1-2 weeks post treatment onset |
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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 | Beast Cancer Subjects | Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans. MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans. | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kirti Kulkarni | University of Chicago | (773) 702-2781 | kkulkarni@radiology.bsd.uchicago.edu |
| 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 |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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