Brain Clinical

脑临床

基本信息

批准号：
7571669
负责人：
PAUL MULLER
金额：
$ 1.91万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7571669
关键词：
Acute Ancillary Study Astrocytoma Biological Preservation Brain Brain Neoplasms Clinical Clinical Research Clinical Trials Consent Control Groups Cyst Detection Dose Eating European Excision Fluorescence Fluorescence Microscopy Gadolinium Goals Image Enhancement Induction of Apoptosis Light Magnetic Resonance Imaging Malignant - descriptor Measurement Mediating Microscopic Neoplasm Metastasis Newly Diagnosed Operative Surgical Procedures Patients Pharmaceutical Preparations Photobleaching Porfimer Sodium Postoperative Period Process Purpose Radiation therapy Randomized Recurrence Recurrent tumor Resected Residual Tumors Sampling Standards of Weights and Measures Supratentorial Surgeon System Techniques Time Tissues Tumor Tissue Unresectable Upper arm Weight Wit brain tissue chemotherapy concept improved in vivo neoplastic cell pre-clinical prospective protoporphyrin IX technology development tumor uptake

项目摘要

The overall goal of project #2 is to improve the survival of patients with malignant primary brain tumors by the use of Photofrin-PDT or by the use of combined fluorescence-guided tumor resection [FGR] and ALA-mediated PDT. Since malignant primary brain tumors rarely metastasize, local tumor control should result in prolongation of survival and a delayed recurrence. Two clinical trials of Photofrin-PDT have been undertaken. Clinical trial #1 is to determine in a randomized two arm clinical study whether the addition of Photofrin-PDT to surgical tumor resection, post-operative "adiation and chemotherapy delays recurrence and increases survival in patients with newly-diagnosed malignant astrocytic tumors. Consented patients were randomized to a no-PDT control group and or to a high light dose [120 J/cm2] PDT group. This trial has now been closed and detailed analysis is in progress. Clinical trial #2 is to determine whether high light dose [120 J/cm2] Photofrin-PDT will delay recurrence and increase survival in comparison to low light dose Photofrin-PDT [40 J/cm2] in patients with recurrent malignant astrocytic tumors. This trial is accruing patients. There is growing evidence that survival is improved by surgically reducing the amount of residual tumor. FGR using ALA [a precursor of protoporphyrin IX, which has a highly selective tumor fluorescence and PDT effect] as the sensitizer is being assessed in European trials using subjective and qualitative intra-operative assessments. In clincical trial #3 we will determine the optimal dose and time of administration of ALA using a quanititative fluorescence detection camera system.

项目＃2的总体目标是通过使用Photofrin-PDT或使用联合荧光引导的肿瘤切除[FGR]和ALA介导的PDT来改善恶性原发性脑肿瘤患者的存活。由于恶性原发性脑肿瘤很少转移，因此局部肿瘤控制应导致生存延长和延迟复发。已经进行了两项光蛋白-PDT的临床试验。临床试验＃1是在随机的两个ARM临床研究中确定是否在手术肿瘤切除中添加光蛋白-PDT是否是否在新近诊断的恶性肿瘤患者中延迟了术后“ Adiation and Adiation and Chemothapic”延迟复发并增加了同意患者的患者。现在已关闭，详细分析正在进行中。与低光剂量光蛋白-PDT [40 J/CM2]相比，复发性恶性星形胶质细胞肿瘤患者的生存率增加。该试验正在累积患者。越来越多的证据表明，通过手术减少残留肿瘤量来改善生存。使用ALA [原源性IX的前体的FGR，它具有高度选择性的肿瘤荧光和PDT 效应]在使用主观和定性术中评估的欧洲试验中评估敏化剂。在Crincical试验＃3中，我们将使用Quanitative荧光检测摄像头系统确定ALA给药的最佳剂量和时间。