minimal invasive treatment with radiofrequency ablation of breast carcinoma in elderly patients(>70 years) who are not or less fit for surgery

minimal invasive treatment with radiofrequency ablation of breast carcinoma in elderly patients(>70 years) who are not or less fit for surgery - radiofrequency ablation of breast carcinoma in elderly patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31718

Enrollment

Registered

2008-08-14

Start date

2008-12-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breastcancer carcinoma of the breast

Interventions

Radiofrequency ablation of T1 breast carcinoma (N0M0)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: -multiple carcinomas in the breast -contra-indications for MR imaging -hormone receptor negative tumors -axillary lymph node metastasis -metastasis in other organs

Design outcomes

Primary

Measure	Time frame
-Feasibility of RFA -Safety of RFA with registration of complications -Efficacy RFA with evaluating possible local tumor recurrence in the breast by MRI and core needle biopsies -Tumor recurrence (other organ than breast) -Patients experience (see also appendix 3 en 4)	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)