Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 123I-mIBG (meta-iodobenzylguanidine)
123I-mIBG · 3 trials · 3 indications
H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as 'Low' and 'High' based on being \<1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.
| Arm | Type | Description |
|---|---|---|
| 123I-mIBG (Meta-iobenzylguanidine) | EXPERIMENTAL | 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. |
| 123I-mIBG (meta-iodobenzylquanidine | EXPERIMENTAL | Single dose |
| 123I-mIBG (meta-iodobenzylguanidine) | EXPERIMENTAL | Single dose |
| Name | Type | Description |
|---|---|---|
| 123I-mIBG (meta-iodobenzylguanidine) | DRUG | - |
Inclusion Criteria: 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) K...
123I-mIBG is an imaging agent used in scintigraphy to evaluate heart failure and to assess patients being evaluated for pheochromocytoma or neuroblastoma. It is a small molecule radiopharmaceutical developed by GE HealthCare Technologies Inc. (GEHC).
123I-mIBG targets the norepinephrine transporter (NET) and is taken up by sympathetic nerve terminals. This uptake allows scintigraphy to visualize cardiac sympathetic innervation and to detect tumors such as pheochromocytoma and neuroblastoma that express the transporter.
123I-mIBG is developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is responsible for the clinical development of the imaging agent.
123I-mIBG is in Phase 3 clinical development. It is an investigational imaging agent and has been studied in completed Phase 3 trials. It is not approved by the FDA for the indications studied.
123I-mIBG has been studied in three completed Phase 3 trials: NCT00126438 and NCT00126425 in heart failure and control subjects, and NCT00126412 in patients evaluated for pheochromocytoma or neuroblastoma. All trials were conducted in the United States.
Yes, 123I-mIBG is the same as meta-iodobenzylguanidine. The abbreviation 123I-mIBG stands for iodine-123 meta-iodobenzylguanidine, which is the full chemical name of the imaging agent.