Clinical trial · Observational
IORT-Breast at Medical Center Navicent Health
Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health
- 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)
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
Conditions
Conditions (2)
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 Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiation Therapy | Radiation | — | UNRESOLVED |
| Lumpectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A- Preoperative Prospective
- description
- Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention.
- interventionNames
- Procedure: Lumpectomy
- Radiation: Intraoperative Radiation Therapy
- label
- Cohort B- Postoperative Prospective
- description
- Subjects who have had IORT performed within the previous 6 month who agree to participate.
- interventionNames
- Procedure: Lumpectomy
- Radiation: Intraoperative Radiation Therapy
Primary outcomes (2)
- measure
- Rate of recurrence
- timeFrame
- 5 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent and HIPAA authorization * T1 tumor (less than or equal to 20mm in greatest diameter) * Unifocal * Histological Grade 1 or 2 * Node Negative * ER +ve * HER-2 -ve Exclusion Criteria: * Previous radiation therapy to the involved breast other than IORT within 6 months * High grade tumors (Histologic grade 3) * Her-2 Positive * Lymphovascular invasion * Metastatic disease * close proximity to or involvement of skin * Multifocal cancer
References
Publications (0)
Data not yet available