CTRI/2026/02/103534尚未招募2 期
To evaluate FAPI as a potential theranostic in soft tissue sarcoma using 68Ga-FAPI-46 PET/CT and 177Lu-FAPI 46 therapy.
All India Institue of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This is a prospective, single arm, open label interventional theranostic study evaluating fibroblast activation protein inhibitor based imaging and radionuclide therapy in patients with metastatic soft tissue sarcoma who have exhausted standard treatment options.
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 soft tissue sarcoma.
- •Metastatic disease
- •Life expectancy greater than 12 weeks
- •For 177Lu-FAPI-2286 therapy, adequate end organ function as given by Hemoglobin more than or equal to 10g/dl, Leucocytes more than or equal to 3000/mcL, Platelets more than or equal to 75,000/mcL, Total Bilirubin less than or equal to 3 x upper limit, AST/ALT/ALP less than or equal to 3 x upper limit, INR less than or equal to 1.5 x upper limit and S.Creatinine less than or equal 1.7 mg/dl.
排除标准
- •Eastern Cooperative Oncology Group [ECOG] performance status more than
- •Pregnant or lactating women.
- •Refusal to give written informed consent or withdrawal of consent at any point of time.
- •Recent anti-cancer chemotherapy/surgery in less than four weeks or radiotherapy less than 8 weeks.
- •Active/acute serious illness/infection uncontrolled by oral medications.
- •Concurrent primary malignancy other than soft tissue sarcoma.
研究者
Yogita Khandelwal
AIIMS, New Delhi
研究点 (1)
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