UTZ GUIDED MINIMALLY INVASIVE TREATMENT OF DEEP TUMORS

UTZ 引导深部肿瘤微创治疗

• 批准号: 6152402
• 负责人: DAN J CASTRO
• 金额: $ 6.63万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-01 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6152402
• 关键词: clinical trials; combination cancer therapy; cooperative study; functional ability; head /neck neoplasm; human subject; human therapy evaluation; laser therapy; magnetic resonance imaging; medical complication; neoplasm /cancer relapse /recurrence; neoplasm /cancer therapy; neoplasm /cancer thermotherapy; ultrasound therapy

Management of far advanced and recurrent head and neck cancer is a common, complex and costly clinical dilemma. One third to one half of all head and neck cancer patients will develop persistent or recurrent disease within the first five years post treatment. Once recurrent after primary treatment,, survival rates for head and neck cancers are very poor. Nearly all of these patients will die within one year, usually with severe functional and cosmetic problems. The role of chemotherapy in management of far advanced head and neck cancer who failed previous surgery and radiation therapy is not fully elucidated. The potential benefit of chemotherapy must be weighed against the potential for systemic toxicity and cost. Recent single/combination chemotherapy trials reported a median survival rate of 6.5 months. An attractive solution to these problems would be the development of a new adjunctive method combining the best features of interstitial therapy for selective tumor destruction via minimally invasive techniques for access and ultrasound (UTZ) or ultrafast magnetic resonance images (MRI) as a monitoring system of the treatment. Interstitial tumor therapy (ITT) is a technique whereby a source of energy (laser, radiofrequency, ultrasonic, cryoenergy, etc.) is directly applied into tumors at various depths. Recent experimental studies have demonstrated the efficiency of UTZ and MRI for real and/or "near" real time tumor and vessel identification as well as monitoring and quantifying energy induced tissue damage. Review of our pilot clinical experience using UTZ guided minimally invasive interstitial Nd:YAG laser/ ultrasonic treatment of recurrent head and neck tumor reveals that the technique is feasible with a median survival rate of 18 months. The overall objectives of this phase II clinical trail are to: 1. Test the effectiveness, practicality and safety of UTZ guided interstitial Nd:YAG laser/ultrasonic palliative tumor therapy in patients with recurrent, unresectable head and neck carcinomas. 2. Evaluate the clinical outcome of therapy as measured by changes in tumor volume, rates of complications and psychosocial functions.

晚期和复发性头颈癌的管理是一个 常见的、复杂的和昂贵的临床困境。三分之一至一半 的头颈癌患者会出现持续或 在治疗后的前五年内复发疾病。一旦 初次治疗后复发，头部和 颈癌的发病率很低。几乎所有的病人都会死亡 一年内，通常有严重的功能和美容 问题化疗在晚期肺癌治疗中的作用 头颈部癌症，既往手术和放疗失败 治疗没有完全阐明。的潜在益处 化疗必须与全身性 毒性和成本。近期单药/联合化疗试验 中位生存率为6.5个月。一个有吸引力 解决这些问题的办法是发展一种新的 结合间质性最佳特征的辅助方法 微创选择性肿瘤破坏治疗 超声（乌茨）或超快磁共振成像技术 磁共振成像（MRI）作为治疗的监测系统。 间质性肿瘤治疗（ITT）是一种技术， 能量（激光、射频、超声波、冷冻能等）是 直接应用于不同深度的肿瘤。最近的实验 研究已经证明乌茨和MRI对于真实的 和/或“接近”真实的时间肿瘤和血管识别以及 监测和量化能量引起的组织损伤。审查 我们的试点临床经验，使用乌茨引导微创 Nd：YAG激光/超声组织间治疗复发性股骨头 颈部肿瘤显示，该技术是可行的， 18个月的生存率。 本II期临床试验的总体目标是： 1.测试乌茨引导的有效性、实用性和安全性 Nd：YAG激光/超声间质内姑息性肿瘤治疗 复发性、不可切除的头颈部癌患者。 2.根据变化评估治疗的临床结局 肿瘤体积、并发症发生率和心理社会功能。