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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 investigational small molecule imaging agent being developed by GE HealthCare Technologies Inc. (ticker: GEHC). It is used in scintigraphy imaging to evaluate cardiac sympathetic nerve function in heart failure and to image tumors such as pheochromocytoma and neuroblastoma. It is currently in Phase 3 clinical development.
123I-mIBG is used for scintigraphy imaging in patients with congestive heart failure to assess cardiac sympathetic innervation. It is also used in imaging evaluations for pheochromocytoma and neuroblastoma. The agent is investigational and has been studied in Phase 3 trials.
123I-mIBG is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is responsible for the clinical development of this imaging agent.
123I-mIBG is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA. Two Phase 3 trials have been completed, and no active trials are currently listed.
123I-mIBG has been studied in completed Phase 3 trials including NCT00126438 and NCT00126425, which evaluated scintigraphy imaging in patients with heart failure and control subjects without cardiovascular disease, and NCT00126412, which evaluated imaging in patients being assessed for pheochromocytoma or neuroblastoma.
Yes, 123I-mIBG is the same as meta-iodobenzylguanidine. 123I-mIBG is the abbreviated name for the radioiodinated compound meta-iodobenzylguanidine, which is used as a scintigraphy imaging agent.