Recruiting
Intra-Operative Radiation Registry
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.
ClinicalTrials.gov IDNCT04994067
PhaseNot Applicable
Enrollment460
SponsorAlbert Einstein College of Medicine
Age18 Years and older
SexFEMALE
Conditions studied
Breast Cancer
About this 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.
Primary outcomes
- Number of patients with locally controlled disease (5 years following radiation therapy)
- Number of patients with regionally controlled disease (5 years following radiation therapy)
- Number of patients with grade 2 or higher toxicities (5 years following radiation therapy)
Eligibility information
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
Study locations
- Montefiore Medical Center - Moses Campus, The Bronx, New York 10467-2490 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.