Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol
Albert Einstein College of Medicine
Summary
This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.
Description
Eligible patients will be referred for radiation oncology consultation by the operating surgeon. Patients will be presented with all radiation options and if they choose IORT, they will be offered enrollment onto the registry trial and consented accordingly. The registry will collect treatment data from the operation, radiation and pathology notes post IORT for each patient enrolled. Sources of research material, i.e. resected breast tissue and lymph nodes, will be obtained as part of routine clinical care. No additional tissue will be collected from patients due to enrollment on this registry…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female gender * Age ≥ 45 * cT1-2N0, \<3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, \< 2.5 cm, estrogen-receptor positive * Suitable for breast conserving surgery * No contraindication to radiation * Mammogram within 6 months of planned procedure * Fitness for lumpectomy under general anesthesia * Planned to receive IORT Exclusion criteria * Known axillary lymph node positive breast cancer (negative biopsy not required) * Multicentric cancer in the same breast as diagnosed by clinical examination, mamm…
Location
- Montefiore Medical Center - Moses CampusThe Bronx, New York