PHOTODYNAMIC TREATMENT OF BENIGN UTERINE DISEASE

良性子宫疾病的光动力治疗

• 批准号: 2463109
• 负责人: YONA TADIR
• 金额: $ 18.01万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-07-03 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2463109
• 关键词: biomedical equipment development; clinical biomedical equipment; clinical research; clinical trial phase I; drug screening /evaluation; endometrium; female; fiber optics; histology; human subject; human therapy evaluation; laboratory rat; laser therapy; light microscopy; pharmacokinetics; photobiology; photosensitizing agents; phototherapy; radiation therapy; scanning electron microscopy; topical drug application; uterus disorder; women's health

DESCRIPTION: The long-term goal of the proposed work is to develop a new, minimally-invasive treatment of benign uterine disease based on Photodynamic Therapy (PDT). Eventually, uterine PDT may have a significant impact on women's health care and its associated costs because it will provide an inexpensive, outpatient alternative to conventional surgical and medical techniques for treating dysfunctional uterine bleeding (DUB) and improving adenomyosis (AM)-related symptoms. During the past six years we have completed a number of animal, human and modeling studies that have helped us understand the complexity inherent to achieving irreversible endometrial ablation (EA) during PDT. We now propose a major new effort which builds on this foundation and further characterizes how light and drug dosimetry parameters affect clinical outcome. Specific aims include: 1) constructing, characterizing and optimizing performance of a novel, minimally-invasive intrauterine light probe (IULP); 2) completing Phase I/II and beginning Phase III human clinical trials with ALA; 3) testing a limited number of new sensitizers in animal models; and 4) evaluating pharmacokinetics, safety and efficacy of a limited number of new compounds in humans.

描述：拟议工作的长期目标是开发一种新的、 基于光动力的子宫良性疾病微创治疗 治疗（PDT）。 最终，子宫 PDT 可能会对 妇女的医疗保健及其相关费用，因为它将提供 廉价的门诊替代传统手术和医疗 治疗功能失调性子宫出血（DUB）和改善的技术 子宫腺肌病 (AM) 相关症状。 在过去的六年里，我们 完成了许多对我们有帮助的动物、人类和模型研究 了解实现不可逆子宫内膜固有的复杂性 PDT 期间的消融 (EA)。 我们现在提出一项重大的新努力，该努力建立在 该基础并进一步描述了光和药物剂量测定如何 参数影响临床结果。 具体目标包括：1) 构建、表征和优化小说的性能， 微创宫内光探头（IULP）； 2）完成第一阶段/第二阶段 并开始 ALA 的 III 期人体临床试验； 3）测试有限 动物模型中新敏化剂的数量； 4）评估 有限数量的新化合物的药代动力学、安全性和功效 在人类中。