Phaeochromocytoma and Neuroblastoma
Conditions
Interventions
Trade Name: Amersham [123I]-mIBG Injection
Product Name: Amersham [123I]-mIBG Injection
Pharmaceutical Form: Solution for injection
CAS Number: 139755-80-9
Concentration unit: MBq/ml megabecquerel(s)/
Sponsors
GE Healthcare Limited and its affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be included in the study if they meet all of the following criteria: (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). 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.). (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
Exclusion criteria
Exclusion criteria: 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 >3.0 mg/dL [265 µmol/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma;Secondary Objective: 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. ;Primary end point(s): The primary efficacy endpoint is focal increased uptake (presence or absence) on planar scintigraphy which is consistent with active tumour (either phaeochromocytoma or neuroblastoma). The primary efficacy endpoint will be used for the primary analysis of imaging procedure’s sensitivity and specificity | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed