EUCTR2004-004386-15-ES进行中（未招募）1 期
Estudio abierto, multicéntrico, en fase 3 con gammagrafía para valorar la captación de 123I mIBG en sujetos evaluados por feocromocitoma o neuroblastoma.
Amersham Health, S.A. como filial de GE Healthcare Limited0 个研究点目标入组 255 人开始时间: 2006年5月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 255
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)a)The subject has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a mIBG scintigraphic examination is clinically appropriate)
- •b) The subject is at least 18 years of age with either:
- •i) Known phaeochromocytoma.
- •ii) Suspected phaeochromocytoma based on abnormal levels of catecholamines or metabolites in the urine or blood with difficult to control chronic or paroxysmal hypertension and/or abnormalities in the adrenal region on ultrasound, CT, or MRI.
- •iii)A diagnosis of a familial or hereditary condition known to be associated with phaeochromocytoma (multiple endocrine neoplasia, von Hippel-Landau disease, neurofibromatosis, etc).
- •(2) The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
- •(3) The subject is male; or a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the results known prior to investigational medicinal product administration) is negative.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1)The subject was previously entered into this study or has participated in any other investigational medicinal product or medical device study within 30 days of enrolment.
- •(2)The subject has a history or suspicion of significant allergic reaction or anaphylaxis to iodide or iodinated imaging agents.
- •(3)The subject presents with any clinically active, serious, life-threatening disease other than neuroblastoma or phaeochromocytoma, with a life expectancy of less than 30 days or where participation in the study might compromise the management of the subject or other reason that in the judgement of the investigator(s) makes the subject unsuitable for participation in the study.
- •(4)The subject has a history of renal insufficiency (serum creatinine more than 3.0 mg/dL [265 micromoles/L]).
- •(5)The subject uses medications that are known to interfere with 123I-mIBG uptake and these medications cannot be safely withheld 24 hours before study procedures.
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