RecruitingNCT04994067

Intra-Operative Radiation Registry

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


Sponsor

Albert Einstein College of Medicine

Enrollment

460 participants

Start Date

Aug 9, 2018

Study Type

OBSERVATIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This registry study tracks outcomes for women with early-stage breast cancer who receive intraoperative radiation therapy (IORT) — a technique that delivers targeted radiation directly to the surgical site during a lumpectomy, rather than over many weeks after surgery. **You may be eligible if...** - You are a woman aged 45 or older - You have early-stage invasive breast cancer (cT1-2, no lymph node involvement, estrogen receptor positive, tumor ≤3.5 cm) OR low-grade DCIS detected by mammogram - You are having breast-conserving surgery (lumpectomy) and are planned to receive IORT - You had a recent mammogram within 6 months **You may NOT be eligible if...** - You have confirmed positive lymph nodes in the armpit - You have multiple cancer sites in the same breast that cannot be removed with one lumpectomy - You carry BRCA1 or BRCA2 gene mutations - You are receiving neoadjuvant (pre-surgery) chemotherapy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

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NCT04994067


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