Intra-Operative Radiation Registry

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04994067

Run by

Albert Einstein College of Medicine

People needed

500

Starts

2018-08-09

Expected to finish

2032-08-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center - Moses Campus — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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