PHOTODYNAMIC TREATMENT OF BENIGN UTERINE DISEASE

良性子宫疾病的光动力治疗

• 批准号: 2889260
• 负责人: YONA TADIR
• 金额: $ 21.11万
• 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/2889260
• 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， 基于光动力学的子宫良性疾病微创治疗 治疗（PDT）。 最终，子宫PDT可能会对 妇女保健及其相关费用，因为它将提供一个 廉价的门诊替代传统的外科和医疗 治疗功能失调性子宫出血（DUB）和改善 子宫腺肌病（AM）相关症状。 在过去的六年里， 完成了许多动物，人类和建模研究，帮助我们 了解实现不可逆子宫内膜异位症 在PDT期间进行消融（EA）。 我们现在提出一项新的重大努力， 这一基础，并进一步表征如何光和药物剂量测定 参数影响临床结果。 具体目标包括：1） 构建、表征和优化一种新颖的， 微创宫内光探针（IULP）; 2）完成I/II期 并开始ALA的III期人体临床试验; 3）测试有限的 动物模型中新致敏物的数量;和4）评估 有限数量的新化合物的药代动力学、安全性和有效性 在人类身上。