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Efficacy of ultrasound guided radiofrequency ablation of breast carcinomas <= 2cm

Efficacy of ultrasound guided radiofrequency ablation of breast carcinomas <= 2cm - LIMA 2 study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38082
Enrollment
24
Registered
2009-06-09
Start date
2010-06-02
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

breast cancer breast carcinoma

Interventions

All patients will be treated in the operation room. First the sentinel node biopsy will be done according to the standard procedure. Pre RFA ultrasound will be done and the tumor size will be measur

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women >18 years diagnosed with a cT1 breast carcinoma Signed informed consent On large core needle biopsy determined tumorcharacteristics (i.e.estrogen and Progesterone receptor status, Bloom and Richardson, Mitose Activity Index and Her2Neu expression)

Exclusion criteria

Exclusion criteria: pregnancy unknown tumorcharacteristics (i.e. estrogen and progestorone receptor status, B&R, MAI and Her2Neu expression) In situ carcinoma

Design outcomes

Primary

MeasureTime frame
1) Histopathological tumor vitality after RFA using NADH staining 2) Margin of tumor free tissue ablated around the tumor

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)