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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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