SIRA-1000 radiofrequency ablation of lumpectomy margins
A Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
This study tests whether using the SIRA-1000 radiofrequency device at the edge of the lumpectomy cavity during breast-conserving surgery can destroy remaining cancer cells in women 50 and older with ER/PR+ invasive ductal breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Innoblative Designs, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT07206121 on ClinicalTrials.gov |
What this trial studies
During lumpectomy the surgeon places the SIRA-1000 device into the surgical cavity and applies radiofrequency energy to ablate tissue at the specimen margins, with a stitch used to stabilize the device and maintain contact. The removed tumor and tissue from the ablated edges are sent for pathology to determine whether the targeted ablation achieved thermal destruction of residual cancer cells. The trial enrolls biologic females aged 50 and older with unicentric, unilateral ER/PR+ Her2- invasive ductal carcinoma ≤3 cm and tumors located at least 2 cm from the skin, while excluding patients with implants, implanted electronic devices, neoadjuvant chemotherapy, multicentric disease, or other listed conditions. The procedure is performed at a single center (University of Texas Medical Branch at Galveston) and the primary focus is on safety and clinical accuracy of margin ablation using the SIRA-1000 as an adjunct to standard surgery.
Who should consider this trial
Good fit: Ideal candidates are biologic females aged 50 or older with a single unilateral ER/PR+ Her2- invasive ductal tumor ≤3 cm, located ≥2 cm from the skin, good performance status (Zubrod 0–2), and no breast implants or implanted electronic devices.
Not a fit: Patients who are pregnant or breastfeeding, have multicentric or bilateral disease, diffuse microcalcifications, prior breast implants, implanted cardiac devices, recent neoadjuvant chemotherapy, or significant cardiac arrhythmias would not be expected to benefit and are excluded.
Why it matters
Potential benefit: If successful, this approach could reduce positive margins and the need for additional surgeries by destroying microscopic cancer at the lumpectomy edges.
How similar studies have performed: Radiofrequency ablation in breast lesions has been explored in prior small studies with mixed results, so using RFA specifically to treat lumpectomy margins is a partly explored but not yet definitively proven approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biologic female 2. 50 years of age and older 3. Confirmed diagnosis of breast cancer: 1. Infiltrating ductal carcinoma 2. ER/PR+Her2neu- 3. Grade I, II, or III 4. Unicentric, unilateral tumor size ≤ 3cm 5. Tumor location ≥ 2 cm from skin and other structures 6. Zubrod Performance Status of 0, 1, or 2 7. No palpable lymphadenopathy 8. Able and willing to provide written informed consent Exclusion Criteria: 1. Pregnant or breastfeeding 2. Neoadjuvant chemotherapy 3. Cardiac arrhythmia 4. Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device 5. Current or history of breast implants 6. Multi-centric or bilateral breast cancer 7. Diffuse microcalcifications 8. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study 9. Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch at Galveston, TX — Galveston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Manager
- Email: kathy@innoblative.com
- Phone: 833-920-4660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.