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

Breast carinoma is the most frequently occuring type of cancer in dutch women;
1/9 women. Diagnoses is mostly determined on large core needle biopsy on which
type, grade and hormonal status can be assessed. Current treatment of T1 breast
carcinoma consists of breast sparing surgical treatment in combination with
local radiotherapy. Known complications of this surgical treatment are post
operative bleeding in up to 11% of the patients and woundinfection in up to
25%. Apart from this the cosmetic outcome can be dissapointing due to formation
of scarring tissue. The cosmetic outcome depends on the breast size in relation
to the tumor size. Whenever complications occur adjuvant treatment is
postponed.
A new minimally invasive treatment modality is radiofrequency ablation (RFA).
This technique has proven to be usefull in the local treatment of colorectal
metastasis in the liver. Possibly this technique can be implemented in women
diagnosed with a T1 breast carcinoma too. In order to apply this techique
reliably there are 4 important steps to be taken. Firstly, both the anatomy and
the exact location of the tumor have to be depicted. Secondly the tumor has to
be localized adequately. Thirdly a reliable technique has to be used to
complete destroy the tumor and finally reliable monitoring of the treatment
should be possible.
Contrast enhanced ultrasound can adequately depict the tumor and this modality
can be used to localize the tumor. As the RFA is able to adequately ablate
liver metastases, possibly it can be used for ablation of breast carcinoma as
well. Studies on RFA in the treatment of breast carcinoma show a overall
overall ablation rate of 90%.
RFA produces highly frequent alternating current which induces heath through
friction of the molecules. RFA coagulated lymph vessels and blood vessels,
therefore contrast enhanced ultrasound could be a good monitoring device.
So far the only complication described is skinburn, possibly this can be
avoided by applying icepackings on the skin overlying the tumor.
It is expected that contrast enhanced ultrasound will be able to assess the
tumor free margins, making the lumpectomy in the future redundant. This aspect
will also be evaluated in this study.

In this study we will evaluate the possibility to locally ablate small breast
carcinomas with RFA. Finally this study should contribute to the replacement of
the conventional lumpectomy by RFA.

1) Can radiofrequency ablation (RFA) completely destroy cT1 (<2cm)
beast carcinoma percutaneously?

Multicentre phase 2 study in which all patients are subjected to the same
procedure

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 measured in 3 directions. This will be
done post RFA too. Furthermore an ultrasound guided RFA procedure will be done
with predetermined RFA settings (time and energy) followed by a standard
lumpectomy.

The extra burden for participating patients consists of an ultrasound guided
RFA treatment. The surgical produre will be delayed with 30 minutes.