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The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery.
Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-operative Radiation Therapy (IORT) | Experimental | Following breast conserving surgery, a CT-based plan will be prepared to deliver highly conformal IORT and the treatment will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-operative Radiation Therapy (IORT) | Radiation | IORT is a form of APBI (accelerated partial breast irradiation) that allows for a high degree of dose homogeneity, exclusion of non-affected structures, and reduction of the volume of breast tissue exposed. |
| Measure | Description | Time Frame |
|---|---|---|
| IORT (Intra-operative Radiation Therapy) treatment interval | Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete | 90 minutes or less |
| Overall incidence of adverse events and major toxicities | Up to 6 months following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| IORT treatment parameters | Gather preliminary data on planning time | up to 6 hours |
| Cosmetic Outcome | Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shayna Showalter, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
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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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| Up to 6 months following treatment |
| Quality of life assessment | Patients will complete a breast cancer specific quality of life survey | Up to 6 months following treatment |
| IORT treatment parameters | gather preliminary data on total radiation delivery time | upto 6 hours |
| IORT treatment parameters | Gather preliminary data on total procedure time | upto 6 hours |
| IORT treatment parameters | Gather preliminary data on dosimetry | upto 6 hours |
| D017437 |
| Skin and Connective Tissue Diseases |