breast cancer breast neoplasms
Conditions
Interventions
Ultrasound guided percutaneous RFA, MWA or cryoablation will be performed 1-2
weeks after diagnosis. Surgical resection will take place about 3 months after
diagnosis. The type of surgical resection
Sponsors
Franciscus Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Woman 2. Pathologically confirmed unifocal primary invasive breast cancer, unilateral 3. A clinical T1 tumor (
Exclusion criteria
Exclusion criteria: 1. History of invasive breast cancer 2. Pregnant or nursing 3. BRCA 1 or 2 positive (if known) 4. Breast augmentation 5. Electrical devices and/or implants 6. Neoadjuvant chemotherapy 7. Triple negative tumors, Her2neu overexpression, Elston/Nottingham grade 3, lobular carcinoma 8. Allergic to local anaesthetics
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: feasibility of the technique, predictive value of MRI for success of the treatment, the degree and type of immune response, learning curve, system usability radiologist, patient satisfaction, patient reported cosmetic outcome, observed cosmetic result (BCCT.core). | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in the pilot study is the percentage of tumours with complete ablation on pathology result 2.5 months after TA. | — |
Countries
Netherlands
Outcome results
None listed