minimal invasive treatment with radiofrequency ablation of breast carcinoma in elderly patients(>70 years) who are not or less fit for surgery
Completed
- Conditions
- breastcancercarcinoma of the breast1000629110006295
- Registration Number
- NL-OMON31718
- Lead Sponsor
- Jeroen Bosch Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
-breastcarcinoma (biopsy proven) with positive estrogenreceptorstatus
-tumor:maximal diameter is 2 cm
-due to comorbidity the tumor is not treatable with surgery or patient does not want to receive surgical treatment
-tumor can be localised using ultrasound
-patient is older than 70 years
-informed consent
Exclusion Criteria
-multiple carcinomas in the breast
-contra-indications for MR imaging
-hormone receptor negative tumors
-axillary lymph node metastasis
-metastasis in other organs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-Feasibility of RFA<br /><br>-Safety of RFA with registration of complications<br /><br>-Efficacy RFA with evaluating possible local tumor recurrence in the breast by<br /><br>MRI and core needle biopsies<br /><br>-Tumor recurrence (other organ than breast)<br /><br>-Patients experience (see also appendix 3 en 4)</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>