An Open-Label, Multicentre, Phase 3 Scintigraphy Study Assessing 123I mIBG Uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma

GE Healthcare Limited and its affiliates0 个研究点目标入组 255 人开始时间: 2005年5月4日最近更新: 2020年10月13日

适应症

试验速览

暂无简介。

•(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 has either:
•i) Known phaeochromocytoma, or
•ii) Suspected phaeochromocytoma based on abnormal levels of catecholamines or metabolites in the urine or blood in conjunction with difficult to control chronic or paroxysmal hypertension and/or abnormalities in the adrenal region on ultrasound, CT, or MRI, or
•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

•Subjects must be excluded from participating in the study if they meet any of the following criteria:
•(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 umol/L]).
•(5) The subject uses medications that are known to interfere with 123I-mIBG uptake and these medications cannot be safely withheld for at least 24 hours before study procedures.

发起方

GE Healthcare Limited and its affiliates