Clinical trial · Interventional
Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer
A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer
NCT02400658CI-TRIAL-00063423active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 early-stage breast cancer at the time of surgery.
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 |
|---|---|---|---|
| IORT with CT-Guided HDR Brachytherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IORT with CT-Guided HDR Brachytherapy
- description
- Patients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery.
- interventionNames
- Device: IORT with CT-Guided HDR Brachytherapy
Primary outcomes (1)
- measure
- Rate of Local Breast Tumor Recurrence
- timeFrame
- Up to 60 Months After Treatment
Secondary outcomes (8)
- measure
- Rate of Ipsilateral Breast Tumor (Not Local) Recurrence
- timeFrame
- Up to 60 Months After Treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer. 2. Tumor size must be less than or equal to 3 cm. 3. Patient is 45 years of age or older. Exclusion Criteria: 1. Male patients. 2. Pregnant patients. 3. Breast cancer that involves the skin or chest wall. 4. History of ipsilateral breast cancer. 5. Multicentric breast cancer in the ipsilateral breast. 6. Known BRCA gene mutation. 7. Patient with nodal disease. 8. Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size. 9. Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).
References
Publications (3)
- DERIVEDReyes-Matos M, Turkheimer LM, Campbell CA, Showalter SL. Beauty Is in the Eye of the Beholder: Cosmetic Outcomes After Precision Breast Intraoperative Radiation Therapy. J Surg Res. 2025 Nov;315:210-217. doi: 10.1016/j.jss.2025.09.029. Epub 2025 Oct 6. PMID 41056841
- DERIVEDTurkheimer LM, Petroni GR, Berger AC, Schroen AT, Brenin DR, Lazar M, Libby B, Janowski EM, Showalter TN, Showalter SL. Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase-II Clinical Trial. J Am Coll Surg. 2024 Jan 1;238(1):10-20. doi: 10.1097/XCS.0000000000000869. Epub 2023 Oct 23. PMID 37870228
- DERIVEDMeneveau MO, Petroni GR, Varhegyi NE, Hulse JC, Schroen AT, Brenin DR, Janowski EM, Berger AC, Lazar MA, Simone NL, Showalter TN, Showalter SL. Toxicity and cosmetic outcomes after treatment with a novel form of breast IORT. Brachytherapy. 2020 Sep-Oct;19(5):679-684. doi: 10.1016/j.brachy.2020.05.002. Epub 2020 Jun 20. PMID 32571746