Consensus Elusive On Design Of Breast Cancer Ablation Registry
This article was originally published in The Gray Sheet
Cost and patient participation will probably be major impediments in developing a registry of breast cancer ablation clinical trials, according to stakeholder comments to FDA
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As the use of breast conserving lumpectomy expands as a treatment for early-stage breast cancer, interest has surged in alternatives to whole breast irradiation. Follow-on radiation treatment is crucial to the success of this therapy, but a significant number of women are either unable or unwilling to undergo the typical treatment course involving five to seven weeks of daily radiation therapy. The device industry is responding with technologies aimed at delivering post-lumpectomy radiation therapy in a more convenient, potentially safer way.
Stakeholders debating appropriate feasibility study protocol for image-guided thermal ablation of early-stage breast cancer are cautioning that increased use of advanced imaging for the procedures may counter some of the anticipated cost benefits
FDA says the development of a patient registry might help industry design better early-stage clinical trials for evaluating ablation as an alternative breast tumor treatment to more invasive surgery