NCT04994067

Intra-Operative Radiation Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 trial. No additional studies will be performed outside of the routine standard of care. Post treatment, the registry will collect data based on the standard of care follow up schedule. Follow-up visits will be scheduled 2-3 weeks post-operatively, as per standard of care, to review the final pathology and for the initial toxicity assessment. Patients found to have positive margins and/or lymph node involvement may require further surgery and/or additional external beam radiation. Additional follow-up visits with radiation oncology will be scheduled at 6 months and 1, 2, 3, 4, and 5 years following IORT. Toxicity will be scored using Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Local control will be evaluated using clinical exam and semi-annual to annual mammograms. All such information will be tracked and recorded into the registry database.

Conditions

• Breast Cancer

Timeline

• Start date: 2018-08-09
• Primary completion: 2028-01-01
• Completion: 2032-08-01
• First posted: 2021-08-06
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States