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18F-mFBG for administration · 1 trial · 1 indication
Change in 18F-mFBG uptake in the total body and the normal heart over time (based on serial PET images) to: * document the time course of global and regional myocardial activity reflecting specific uptake and clearance of the radiopharmaceutical; * estimate individual organ and whole-body radiation dosimetry.
To demonstrate the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of HF subjects with significant LV dysfunction (LVEF≤35%).
| Arm | Type | Description |
|---|---|---|
| Low likelihood of coronary heart disease | OTHER | Thorax and total body imaging for quantification of normal biodistribution and myocardial sympathetic innervation. PET imaging to 210 minutes post-administration. |
| Heart Failure + left ventricular function (LVEF ≤ 35%) | OTHER | Thorax and total body imaging for quantification of myocardial sympathetic innervation. PET imaging to 100 minutes post-administration |
| Name | Type | Description |
|---|---|---|
| 18F-mFBG for intravenous administration | DRUG | Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent |
Inclusion Criteria: * ≥ 18 years of age at study entry * able and willing to comply with study procedures * signed and dated informed consent is obtained * male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation ...
18F-mFBG for administration is an investigational small molecule being studied for use in cardiovascular diseases. It is being evaluated as a radiotracer for imaging myocardial sympathetic innervation, which relates to the heart's nerve function. The drug is in Phase 1 clinical development and is not yet approved.
18F-mFBG for administration is being developed by Illumina, Inc., a company traded on the NASDAQ under the ticker ILMN. The drug is currently in Phase 1 clinical development for cardiovascular diseases.
18F-mFBG for administration is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for use in cardiovascular diseases, specifically for imaging myocardial sympathetic innervation.
18F-mFBG for administration has been studied in one clinical trial, identified as NCT04535193. This was an open-label, controlled Phase 1 study titled 'Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation.' The trial was completed in the United States and enrolled 10 participants, including healthy volunteers.
18F-mFBG for administration is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for cardiovascular diseases. The drug has completed a Phase 1 trial, but it remains under investigation and has not been approved for any use.