Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04535193 | Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation | PHASE1 | COMPLETED | 10 | — | — | Nov 5, 2021 | Mar 7, 2025 | May 7, 2025 | 1 | United States |
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 ...