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Intra-Operative Radiation Registry for Breast Cancer

This study is a registry, which means it tracks information about a treatment called Intra-Operative Radiation Therapy (IORT) for women with early-stage breast cancer. IORT is a type of radiation given during surgery. The study aims to see how well IORT controls the cancer locally (in the breast) and regionally (in nearby lymph nodes) over 5 years, and to monitor any side effects. You might be able to join if you are a woman aged 45 or older with certain types of breast cancer (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) and are suitable for breast-conserving surgery. The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning it collects information without assigning treatments. It plans to enroll 500 participants.
What's involved
You would have follow-up visits with your doctor 2-3 weeks after surgery, then at 6 months, and annually for 5 years after IORT. These visits include clinical exams and mammograms.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after receiving Intra-Operative Radiation Therapy (IORT).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04994067

Intra-Operative Radiation Registry

Recruiting
Not specifiedAges 18+Observational
Albert Einstein College of Medicine
~500 participants
Updated 2025-09-23 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with locally controlled disease
Measured over 5 years following radiation therapy
+2 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaESR1 Gene

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jana Fox, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Jana Fox, MD
[email protected]
718-920-4140
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of patients with locally controlled disease5 years following radiation therapy

    How many patients have recurrent disease following intra-operative radiation

  • Number of patients with regionally controlled disease5 years following radiation therapy

    How many patients have recurrent nodal disease following intra-operative radiation

  • Number of patients with grade 2 or higher toxicities5 years following radiation therapy

    How many patients have toxicity as measured by the CTCAE