Approval Probability
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Adjusted LOA
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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 a small molecule radiopharmaceutical being developed for use in heart failure and pheochromocytoma. It is an investigational imaging agent studied in patients with congestive heart failure and in patients being evaluated for pheochromocytoma or neuroblastoma. It is not approved and remains in clinical development.
123I-mIBG is being developed by GE HealthCare Technologies Inc., traded on the New York Stock Exchange under the ticker GEHC. The company is conducting clinical trials of this investigational imaging agent in the United States.
123I-mIBG is in Phase 3 clinical development. It is an investigational agent and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with no active trials currently ongoing.
123I-mIBG has completed three Phase 3 trials. NCT00126412 evaluated imaging in patients with pheochromocytoma or neuroblastoma. NCT00126425 and NCT00126438 studied imaging in patients with heart failure and control subjects without cardiovascular disease. All trials were completed in the United States.
Yes, 123I-mIBG is also known as meta-iodobenzylguanidine (123I mIBG). Clinical trial titles refer to the agent as Meta-Iodobenzylguanidine (123I mIBG) Scintigraphy, confirming that 123I-mIBG and meta-iodobenzylguanidine refer to the same investigational imaging agent.