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Press Releases
| Women & Infants Participating in Multi-Institutional Trial of Cryo-Assisted Lumpectomy |
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11/03/04
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Submitted by Jennifer Gass, MD, clinical director, Breast Health Center
In Rhode Island, 85% of women participate in screening mammography. This has lead to the diminishing size of the index breast cancer lesion, with the median size at presentation reaching 1.5 cm. The majority of lesions are non-palpable, picked up only due to screening mammography.
These events have increased the number of women who present for breast cancer surgery as not only candidates for breast conservation, but who also require a means of localization of the non-palpable lesion. Traditionally this task has been achieved in the Radiology Department, via mammographic guidance facilitating the placement of a barbed wire (Kopan’s needle) into or near the non-palpable cancer. Through this technique, tens of thousands of women have undergone cancer operations with breast conservation.
Over the past several years, ultrasound has moved to the forefront as a localizing tool. The development of high resolution ultrasound has made this imaging modality the localization vehicle of choice. Today, the majority of women can have their non-palpable cancer localized by ultrasound while lying comfortably, face upward, on a stretcher, rather than standing in a mammography unit. Furthermore, breast ultrasound has developed a new, premier and unparalleled role in the primary office-based assessment of the breast. This new found diversity of use has lead to a new generation of smaller, ever more portable units. Enhanced portability enabled the ultrasound unit to come to the patient in the office and in the operating room.
In the operating room, ultrasound can be used to localize and direct the therapy of breast lesions. Women & Infants’ Breast Health Center is participating in a multi-institutional trial of cryo-assisted lumpectomy. Under this protocol, women with carcinomas of ductal histology that are 1.7 cm and less and ultrasound visible are randomized to either a traditional localization in radiology preoperatively or an intra-operative localization with ultrasound guidance, and then subsequent placement of an eleven gauge cryo probe into cancer.
With continuous monitoring under ultrasound visiualization, a zone of freezing is created which ultimately engulfs the cancer. The frozen zone in enlarged to a maximal dimension just 8 mm beyond the previously defined tumor extension. Using this approach a pilot study has shown a greater attainment of clear margins at first surgery, as well as the opportunity to avoid over zealous removal of extra tissue. The creation of the very palpable “ice ball” converts the cancer from a non-palpable one, thus enabling a more exacting excision.
To date, nine patients have been randomized at Women & Infants. There have been no complications, and patients have all given quite positive feedback.
The goals of this study are to evaluate this technique’s ability to achieve negative margin status at initial surgery, thus eliminating the need to take the patient back for re-excision, as well as limit the amount of tissue removed above and beyond what is necessary, potentially resulting in improved comesis and perhaps improved candidacy for brachytherapy delivered by mammosite catheter. But the longer range outlook for Cryo Therapy (which involves a freeze, thaw, and refreeze cycle resulting in cellular destruction) is as an ablative technique for breast cancer. Already a “work in progress report” describes 100% success with cryo-ablation of cancers under one centimeter.
Clearly, further refinement of the technique is imperative, yet it gives tangible hope to the idea that ultimately breast cancer would be percutaneously destroyed in a physicians’ office without the need for surgical excision. |
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