Meta-Iodobenzylguanidine (123I mIBG) Scintigraphy in Patients Being Evaluated for Phaeochromocytoma or Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00126412|
Recruitment Status : Completed
First Posted : August 4, 2005
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pheochromocytoma Neuroblastoma||Drug: 123I-mIBG (meta-iodobenzylguanidine)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicentre, Phase 3 Scintigraphy Study Assessing 123I-mIBG Uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma|
|Actual Study Start Date :||August 2, 2005|
|Actual Primary Completion Date :||September 27, 2006|
|Actual Study Completion Date :||September 27, 2006|
Experimental: 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.
Drug: 123I-mIBG (meta-iodobenzylguanidine)
- - To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126412
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Diane McCaul||GE Healthcare|