A pilot study to assess the status of 177Lu-FAPI as a potential theranostic agent in recurrent glioblastoma multiforme patients
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess FAP expression in-vivo in recurrent glioblastoma multiforme patients using 68Ga-FAPI (46/2286) PET/CT.
研究概览
简要总结
Glioblastoma multiforme GBM is the most common and aggressive primary malignant brain tumor in adults accounting for about 45 percent of cases. It is classified as a World Health Organization grade IV tumor characterized by endothelial proliferation and necrosis with a poor prognosis. The median overall survival is 12 to 15 months and the five year survival rate is only 4 to 5 percent. Standard management includes magnetic resonance imaging based diagnosis followed by maximal safe surgical resection and concurrent chemoradiation with temozolomide. Prognosis depends on factors such as age performance status and MGMT promoter methylation which predicts better response to temozolomide.
Despite aggressive treatment recurrence occurs in 80 to 90 percent of cases near the resection site and few advances have been made since bevacizumab approval in 2009. Recent research has focused on novel theranostic approaches targeting fibroblast activation protein FAP which is highly expressed in the tumor microenvironment of GBM but minimally in normal tissues.
Lutetium 177 labeled FAP inhibitors Lu 177 FAPI offer a promising strategy by combining diagnostic imaging and targeted beta therapy. Lutetium 177 emits medium energy beta particles with limited tissue range and low energy gamma photons suitable for imaging. Although studies on Lu 177 FAPI in GBM are limited early findings are encouraging and support further evaluation of this agent as a potential theranostic option in recurrent glioblastoma multiforme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 18 years or above and providing written consent.
- •Histological confirmation of glioblastoma.
- •Advanced-stage disease with FAPI avid recurrence on 68Ga-FAPI PET/CT scan.
- •Progressive disease after standard-of-care treatment.
- •Life expectancy greater than 12 weeks.
- •For 177Lu-FAPI-46 therapy, adequate end organ function 4 weeks before study, as given by Hemoglobin more than or equal to 10g/dl.
- •Leucocytes more than or equal to 3000/mcL.
- •Total Bilirubin less than or equal to 3 x upper limit.
- •AST/ALT/ALP less than or equal to 3 x upper limit.
排除标准
- •Eastern Cooperative Oncology Group performance status more than
- •Pregnant or lactating women.
- •Refusal to give written informed consent.
- •Uncontrolled intercurrent illness.
结局指标
主要结局
To assess FAP expression in-vivo in recurrent glioblastoma multiforme patients using 68Ga-FAPI (46/2286) PET/CT.
时间窗: 0-12 months
次要结局
- (1) To assess the biodistribution and tumor retention of FAPI based therapeutic radiopharmaceutical (177Lu-FAPI 46/2286). (2) To assess the safety and efficacy of 177Lu-FAPI (46/2286) therapy in study population using clinical parameters, PERCIST, MRI brain and Overall Survival (OS) after treatment.
研究者
Dr Nishikant Avinash Damle
All India Institute of Medical Sciences, New Delhi
