Clinical assessment of the tissue distribution of [18F]FMISO, INJ SOL after intravenous injection in patiens with malignancy

RadioMedic s.r.o.0 个研究点开始时间: 2012年10月22日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•persons of both sexes of age 18 – 80 years
•proven squamous cells carcinoma bearing, verified by PET scintigraphy using [18F]FDG, verified histologically
•[18F]FDG PET examination performed for medical indication within 28 days before ivestgational preparation administration
•signing the informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•suspicion of drug addiction
•infectious or acute febrile illness within last 14 days before signing of informed consent
•application of ionizing radiation from research reasons within last 10 years
•chemotherapy finished in shorter term then 4 weeks or radiotherapy finished in shorter term then 3 months before application of testing preparation
•suspicion of pregnancy (laboratory test of fertile age women with opportunity of pregnancy), nursing mother
•significant renal disease (S-creatinine > 50% above upper normal limit, urea > 50% above upper normal limit)
•significant signs of haemopoiesis (leukopenia < 1,5 x 10-9 / L, thrombocytopenia < 80 x 10-9 / L)
•participation in another study
•inability to co-operation
•foreign nationality
•person with limited legal capacity
•dependent person (military service, punishment)

发起方

RadioMedic s.r.o.