Intra-Operative Radiation Registry

September 18, 2025 updated by: Albert Einstein College of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Eligible patients will be referred for radiation oncology consultation by the operating surgeon. Patients will be presented with all radiation options and if they choose IORT, they will be offered enrollment onto the registry trial and consented accordingly. The registry will collect treatment data from the operation, radiation and pathology notes post IORT for each patient enrolled. Sources of research material, i.e. resected breast tissue and lymph nodes, will be obtained as part of routine clinical care. No additional tissue will be collected from patients due to enrollment on this registry trial. No additional studies will be performed outside of the routine standard of care.

Post treatment, the registry will collect data based on the standard of care follow up schedule. Follow-up visits will be scheduled 2-3 weeks post-operatively, as per standard of care, to review the final pathology and for the initial toxicity assessment. Patients found to have positive margins and/or lymph node involvement may require further surgery and/or additional external beam radiation. Additional follow-up visits with radiation oncology will be scheduled at 6 months and 1, 2, 3, 4, and 5 years following IORT. Toxicity will be scored using Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Local control will be evaluated using clinical exam and semi-annual to annual mammograms. All such information will be tracked and recorded into the registry database.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467-2490
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Jana Fox

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients enrolled on this study will be planned for lumpectomy with or without sentinel node biopsy for early stage breast cancer. Patients will be evaluated by a radiation oncologist who specializes in the treatment of breast cancer and will be deemed to be eligible for IORT. Patients with a history of ipsilateral cancer and/or prior in-field radiation are eligible, as IORT would likely be less toxic than repeat whole or partial breast external beam radiation and can allow patients to avoid mastectomy who wish to do so.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with locally controlled disease
Time Frame: 5 years following radiation therapy
How many patients have recurrent disease following intra-operative radiation
5 years following radiation therapy
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
5 years following radiation therapy
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
5 years following radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Investigators

  • Principal Investigator: Jana Fox, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

August 1, 2032

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-9409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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