Registry for tracking intraoperative radiation therapy in breast cancer patients
Official title: Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol
Run by Albert Einstein College of Medicine · NCT04994067 · Data updated 2026-11-12
This study tracks how well intraoperative radiation therapy works and its side effects in women with early-stage breast cancer who choose this treatment option.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 460 (estimated) |
| Sponsor | Albert Einstein College of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | August 9, 2018 |
| Main results expected | January 2028 |
| Study ends | August 2032 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT04994067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 45 and older with early-stage, estrogen-receptor positive breast cancer suitable for breast-conserving surgery.
✕Probably not a fit
Patients with known axillary lymph node positive breast cancer or those undergoing neoadjuvant chemotherapy may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry aims to monitor local control rates and side effects of intraoperative radiation therapy (IORT) for women with early-stage breast cancer who meet the latest ASTRO guidelines for partial breast irradiation. Eligible patients will be referred for consultation and, if they choose IORT, will be consented for enrollment. The registry will collect treatment data from clinical notes and follow-up visits, assessing toxicity and local control over a period of five years. No additional tissue will be collected beyond standard clinical care.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of IORT, potentially improving treatment options for breast cancer patients.
How similar studies have gone: While this approach is observational, similar registries have shown success in tracking treatment outcomes in breast cancer, suggesting potential for valuable data collection.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Jana Fox, MD — Montefiore Medical Center
- Study coordinator: Jana Fox, MD
- Email: jfox@montefiore.org
- Phone: 718-920-4140
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.