Become a Patient
Veronesi’s method is incorporated into an IOERT surgical protocol established by Dr. Robert Gardner, Identifier Number RGF100, dated January 17, 2009, “SURGERY AND INTRAOPERATIVE ELECTRON RADIATION THERAPY (IOERT) AS EITHER AN INTRAOPERATIVE BIO-BOOST OR AS FULL DOSE PARTIAL BREAST IRRADIATION FOR BREAST CANCER—A COMMUNITY PRACTICE BASED OBSERVATIONAL PROTOCOL”. In March 2009, the protocol obtained a Western Institutional Review Board approval. A second protocol is under development by Dr. Gardner to treat more advanced cases of breast cancer.
All early stage, phase I and II, breast cancer patients are candidates for IOERT subject to the eligibility and exclusion criteria delineated in Dr. Gardner’s Protocol number RGF100 (Index 10.7.3) but generally open to all women between the ages of 18 and 96 with lesions less than 2.5 cm in size that are non-pregnant/non-lactating and have no history of autoimmune disease.
The five treatment groups of IOERT eligible patients are:
Group 1—SurRad™ Single Dose Treatment (40%)
- 21 gray of IOERT single dose treatment at time of surgery
- Diagnosed with invasive ductile cancer as a candidate for lumpectomy (segmental re-section)
- Post-menopausal with tumor size of 1.5 cm or smaller
- Present clear margins or focal involvement only
- Four or fewer positive axillary lymph nodes
- Candidates for minimal oncoplastic reconstruction by the cancer surgeon
Group 2—SurRad™ BIO-Boost Treatment + Post-operative EBRT (40%)
- 10 gray of IOERT treatment boost at time of surgery with 16 hypo-fractionated doses of conventional EBRT post-operatively
- Diagnosed with invasive ductile cancer, lobular cancer, or ductile carcinoma in-situ as a candidate for partial mastectomy, segmentomy, or lumpectomy
- Over 18 years of age with tumor size below 5 cm
- No Lupus or autoimmune disease present
Group 3—SurRad™ Nipple Sparing Mastectomy (14%)
- IOERT irradiation of the nipple/areola complex
- Diagnosed with more extensive cancer of any type but not involving the tissues behind or in the nipple complex
- Glandular replacement therapy required
- Requiring more extensive reconstruction to be performed by a plastic surgeon
Group 4—Others (4%)
- Qualify for treatment under the second SurRad™ protocol (currently under development)
Group 5—Off Protocol (2%)
- Require something less than full mastectomy
- Diagnosed with Hodgkin’s disease or have had mantle radiation for Hodgkin’s
- Do not fall under the requirements of either protocol
- Breast implants present
- Informed consent required