Clinical trial · Interventional
IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
A Pilot, Single Arm, Study of the Safety and Feasibility of Single-Fraction Intraoperative Radiation Treatment (IORT) With CT-On-Rails-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery. Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative Radiation Therapy (IORT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intra-operative Radiation Therapy (IORT)
- description
- Following breast conserving surgery, a CT-based plan will be prepared to deliver highly conformal IORT and the treatment will be administered.
- interventionNames
- Radiation: Intra-operative Radiation Therapy (IORT)
Primary outcomes (2)
- measure
- IORT (Intra-operative Radiation Therapy) treatment interval
- timeFrame
- 90 minutes or less
- description
- Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete
- measure
- Overall incidence of adverse events and major toxicities
- timeFrame
- Up to 6 months following treatment
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Women 50 years of age of older * Patient has elected breast conserving surgical treatment for early-stage breast cancer * Patient meets American Society for Therapeutic Radiation Oncology (ASTRO) criteria for a "suitable" or "cautionary" patient * Life expectancy of more than 2 years * Tumor size 4cm or less * Women of childbearing potential must agree to use adequate contraception Exclusion Criteria: * Male * Pregnant or nursing * Any contraindication to radiotherapy * Breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast * Patient meets any of the ASTRO criteria for an "unsuitable" patient * Patient requires chemotherapy within two weeks of IORT * Breast implants * A serious uncontrolled medical disorder * Significant history of uncontrolled cardiac disease or CNS disease
References
Publications (0)
Data not yet available