NCT04994067 · Albert Einstein College of Medicine
Intra-Operative Radiation Registry
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Number of patients with locally controlled disease
Time frame: 5 years following radiation therapy
How many patients have recurrent disease following intra-operative radiation
Number of patients with regionally controlled disease
Time frame: 5 years following radiation therapy
How many patients have recurrent nodal disease following intra-operative radiation
Number of patients with grade 2 or higher toxicities
Time frame: 5 years following radiation therapy
How many patients have toxicity as measured by the CTCAE
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Female gender
- 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
Where
- The Bronx, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2025 · Source of record for eligibility and locations