RecruitingNCT04994067

Intra-Operative Radiation Registry

Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol

Sponsor

Albert Einstein College of Medicine

Enrollment

500 participants

Start Date

Aug 9, 2018

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria5

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