Intensity Modulated Breast Brachytherapy System

描述（由申请人提供）：本I期项目的总体目标是证明输送强度调制乳腺近距离放射治疗的可行性，允许基于球囊的乳腺近距离放射治疗更好地符合患者解剖结构，通过减少皮肤剂量降低潜在毒性，并允许将该技术应用于更多因次优皮肤间距而被排除的患者。这将通过设计一系列施源器和治疗计划策略来实现，以促进使用它们。乳腺癌是美国女性中最常见的恶性肿瘤。保乳治疗，包括乳房肿瘤切除术和全乳房放射治疗，已成为早期癌症患者的标准治疗选择。然而，加速部分乳房照射（APBI），现在正在NSABP/RTOG III期临床试验下进行测试，可以在4-5天内提供每日两次治疗的加速放射治疗过程，从而显着缩短整体治疗时间，并可能降低医疗保健成本。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，并使更多的女性可以选择这种治疗。随着MammoSite球囊施源器的开发，人们对使用APBI的兴趣加快。然而，MammoSite的剂量测定特性并不完全理想。MammoSite的皮肤剂量可能相当高，引起关注，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。这种技术创新将精心设计的屏蔽施源器与低能量HDR源结合使用，以实现强度调制乳腺近距离放射治疗，这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，并允许对乳腺近距离放射治疗患者进行更适形的剂量分布。这一发展将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。强度调制乳腺近距离放射治疗系统-公共卫生相关性：基于169镱的强度调制乳腺近距离放射治疗的临床实施将通过降低各种皮肤毒性的概率使患者受益，并允许更多因皮肤毒性而被排除的患者接受乳腺近距离放射治疗。这样的发展将降低这些患者的放射治疗成本，因为加速部分乳房照射的过程要短得多。

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.