Registry for tracking intraoperative radiation therapy in breast cancer patients
Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Albert Einstein College of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT04994067 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 45 and older with early-stage, estrogen-receptor positive breast cancer suitable for breast-conserving surgery.
Not a fit: Patients with known axillary lymph node positive breast cancer or those undergoing neoadjuvant chemotherapy may not benefit from this registry.
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 performed: While this approach is observational, similar registries have shown success in tracking treatment outcomes in breast cancer, suggesting potential for valuable data collection.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.