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| ID | Type | Description | Link |
|---|---|---|---|
| 106406 | Other Identifier | USF IRB |
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The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment.
In order to validate metallic marker placement and stability, patients will have the internal metallic markers placed at the time of their last breast surgery (either lumpectomy or re-excision for margins) by the surgeon and are permanent. They will undergo routine 3D CT-based treatment planning and will receive routine radiation treatment to the whole breast or partial breast as determined by the treating physician. Daily images of the breast will be obtained throughout treatment using the online portal imaging system. These images will be analyzed for the daily position of the metallic markers and compared across the entire course of treatment to determine the stability of metallic markers placement and to assess their efficacy as positioning devices for image guided radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Breast Radiation | 1. Patients receiving Partial breast radiation |
| |
| Whole Breast Radiation | 2. Patients receiving whole breast radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-contrast Computed Tomography (CT) Scans (Metallic Markers) | Device | Non-contrast CT Scans prior to start of radiation therapy, and during weeks 2, 4, 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positional Stability of Metallic Markers in the Breast Parenchyma | To validate that intraparenchymal metallic markers placed in the breast tissue can be used as stable markers throughout a course of radiation treatment for daily image guided localization. Image Guided Radiation Therapy (IGRT) will be deemed feasible if the average shift in marker position results in deviations of up to 7 mm from the initial position. | Completion of planned radiation treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Research subjects will be recruited from the clinical practice of the Breast Program referred for radiation therapy at Moffitt Cancer Center who meets the eligibility criteria. This provides a potential pool of about 450 patients over a 12 month period.
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| Name | Affiliation | Role |
|---|---|---|
| Eleanor Harris, M.D. | H. Lee Moffitt Cancer Center and Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute, Inc. | Tampa | Florida | 33612 | United States |
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| Non-contrast CT Scans (Metallic Markers) | Device | Non-contrast CT Scans prior to start of radiation therapy and on Day 5. |
|
| 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 |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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