An Open-Label, Multicentre, Phase 3 Scintigraphy Study Assessing 123I-mIBG Uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- - To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.
研究概览
简要总结
The study is designed to study the effectiveness of 123I-mIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroblastoma or phaeochromocytoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For subjects recruited under Amendment 01 :
- •(1) a) The subject has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a 123I-mIBG scintigraphic examination is clinically appropriate) OR b) The subject is ≥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, computerised tomography (CT), or magnetic resonance imaging (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).
- •For subjects recruited under Amendment 02 :
- •a) The subject has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a 123I-mIBG scintigraphic examination is clinically appropriate) OR 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).
- •All subjects: (enrolled under Amendments 01 and 02)
- •The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
- •The subject was male; or a female who was either pre-menarchal, surgically sterile (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 (IMP) administration) was negative.
排除标准
- •The subject was previously entered into this study or had participated in any other investigational medicinal product or medical device study within 30 days of enrolment.
- •The subject had a history or suspicion of significant allergic reaction or anaphylaxis to iodide or iodinated imaging agents.
- •The subject presented 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 would compromise the management of the subject or other reason that in the judgement of the investigator(s) made the subject unsuitable for participation in the study.
- •The subject had a history of renal insufficiency (serum creatinine >3.0 mg/dL [265 μmol/L]).
- •The subject used medications that are known to interfere with 123I-mIBG uptake and these medications could not be safely withheld for at least 24 hours before study procedures.
研究组 & 干预措施
123I-mIBG (Meta-iobenzylguanidine)
All subjects received 123I-mIBG injection over at least 1 to 2 minutes through a cannula (or indwelling catheter in the vein). After the injection of 123I-mIBG was complete, the cannula was flushed with at least 5 mL of 0.9% sodium chloride solution over a maximum of 10 seconds.
All subjects ≥18 years of age and children with a weight of ≥70 kg were to receive an intravenous injection of 370 ±10% MBq (333 to 407 MBq [9.0 to 11 mCi] of 123I-mIBG). Doses of 123I-mIBG for children <18 years of age (with a weight of 8-70 kg) were to be calculated on the basis of a reference activity for an adult scaled to body weight according to the schedule proposed by the European Association of Nuclear Medicine (EANM) Paediatric Task Group; for children <8 kg, a scaled activity or a fixed minimum activity of 80 ±10% MBq (72 to 88 MBq [1.9 to 2.2 mCi]) was permissible.
干预措施: 123I-mIBG (meta-iodobenzylguanidine) (Drug)
结局指标
主要结局
- To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.
次要结局
- To determine the incremental value of single-photon emission computed tomography (SPECT) for improving the sensitivity and specificity of 123I-mIBG planar scintigraphy for the diagnoses of neuroblastoma and phaeochromocytoma.
- To collect safety data on 123I-mIBG.