123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors | NCT01373736 | Trialant
Unknown statusInterventionalPhase 3Updated Jun 15, 2011
123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
ClinicalTrials.gov ID
NCT01373736
Lead Sponsor
Vancouver Coastal HealthOTHER_GOV
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 3
Last Update Posted
Jun 15, 2011Estimated
Brief Summary
The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors.
Pheochromocytoma
Neuroblastoma
Paraganglioma
Medullary Thyroid Carcinoma
Carcinoid Tumors
123I-meta-iodobenzylguanidine
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have a clinical indication for 123I-MIBG imaging to evaluate for the presence, extent, or status of neuroendocrine tumors;
subjects must be able and willing to comply with study procedures.
Exclusion Criteria:
Subjects with history of renal insufficiency (serum creatinine level > 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;
Subjects unable to tolerate lying supine;
Subjects pregnant or breastfeeding, unless the information to be gained outweighs the possible hazardous effects of 123I-MIBG administration. Where the assessment of the risk/benefit ration suggests the use of 123I-MIBG in nursing mothers, the breastfeeding should be discontinued for at least 48 hours post-injection.