Intensity Modulated Breast Brachytherapy System

描述（由申请人提供）：这个I期项目的总体目标是证明提供强度调节乳房近距离治疗的可行性，允许基于气球的乳房近距离治疗更好地符合患者解剖结构，通过减少皮肤剂量减少潜在毒性，并允许该技术应用于更多因皮肤间距次优而被排除的患者。这将通过设计一系列涂抹器和治疗计划策略来实现，以方便使用它们。乳腺癌是美国女性中最常见的恶性肿瘤。保乳治疗包括乳房肿瘤切除和全乳放射治疗，已成为早期癌症患者的标准治疗选择。然而，目前正在NSABP/RTOG III期临床试验中测试的加速部分乳房照射（APBI）可以在4-5天内提供每日两次的加速放射治疗过程，从而显着缩短总体治疗时间并可能降低医疗保健费用。这种缩短的治疗时间表减轻了接受乳房保护治疗的患者的护理负担，消除了许多患者的后勤问题，并使更多的妇女可以使用这种选择。随着MammoSite球囊应用器的发展，人们对APBI的使用也越来越感兴趣。然而，乳腺钼靶的剂量学特征并不完全理想。使用乳腺钼靶的皮肤剂量可能相当高，引起人们的关注，因为纤维化、毛细血管扩张和萎缩性皮炎是高皮肤剂量的常见晚期后果。这项技术创新将精心设计的屏蔽涂抹器与低能量HDR光源结合使用，以实现强度调制的乳房近距离治疗，将为临床医生提供一种可以减少皮肤剂量的工具，从而降低皮肤毒性的可能性，并允许乳房近距离治疗患者更符合剂量分布。这一进展将允许更多的患者接受乳房近距离治疗，而现在由于担心皮肤毒性而被排除在外。调强乳房近距离放射治疗系统-公共卫生相关性：基于169镱的调强乳房近距离放射治疗的临床实施将通过减少各种皮肤毒性的可能性使患者受益，并允许更多的患者接受乳房近距离放射治疗，这些患者现在因担心皮肤毒性而被排除在外。这一进展将降低这些患者的放射治疗费用，因为加速部分乳房放射治疗的过程要短得多。

DESCRIPTION (provided by applicant): The overall objective of this Phase I program is to demonstrate the feasibility of delivering intensity modulated breast brachytherapy, permitting balloon-based breast brachytherapy to better conform to patient anatomy, reduce potential toxicity by reducing skin dose, and permit this technique to be applied to a greater number of patients who would now be excluded due to suboptimal skin spacing. This will be achieved through the design of a series of applicators and a treatment planning strategy to facilitate employing them. Breast cancer is the most common malignancy among women in the United States. Breast conservation treatment, consisting of lumpectomy and whole-breast radiation therapy, has become the standard treatment option for patients with early stage cancer. However, Accelerated Partial Breast Irradiation (APBI), now being tested under an NSABP/RTOG Phase III clinical trial, can deliver an accelerated course of radiation therapy in 4-5 days of twice-daily treatments, thus significantly shortening the overall treatment duration and potentially reducing health care costs. This shortened treatment schedule decreases the burden of care for patients undergoing breast conservation treatment, eliminating the logistical problems for many patients, and making this option available to more women. Interest in the use of APBI accelerated with the development of the MammoSite balloon applicator. However, the dosimetric characteristics of the MammoSite are not entirely ideal. The skin dose with the MammoSite can be quite high, causing reason for concern as fibrosis, telangiectasias, and atrophic dermatitis are common late consequences of high skin doses. This technological innovation of applying carefully designed shielded applicators in conjunction with a low-energy HDR source to achieve intensity modulated breast brachytherapy will provide clinicians with a tool that can reduce skin dose, thereby reducing the probability of skin toxicities and permit more conformal dose distribution to breast brachytherapy patients. This development will permit many more patients to receive breast brachytherapy who would now be excluded because of concern for skin toxicity. Intensity Modulated Breast Brachytherapy System - PUBLIC HEALTH RELEVANCE: The clinical implementation of Intensity Modulated Breast Brachytherapy based on 169Ytterbium will benefit patients by reducing the probability of a variety of skin toxicities and permit many more patients to receive breast brachytherapy who would now be excluded because of concern for skin toxicity. Such a development would reduce the cost of radiation therapy for these patients, as the course of accelerated partial breast irradiation is much shorter.