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Intra-Operative Radiation Registry
RecruitingObservational study
Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol
Who can join
Ages 18 and older · Women
Full eligibility criteria
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, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy. * Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene * Patients undergoing neoadjuvant chemotherapy * Pregnancy
About the study
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.
Sponsor: Albert Einstein College of Medicine · Participants: 460 · Started: Aug 9, 2018
Contact the study team
- Jana Fox, MD · Phone: 718-920-4140
Official record on ClinicalTrials.gov — NCT04994067
Locations in the U.S.
| New York | Montefiore Medical Center - Moses Campus, The Bronx |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.