Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT04535193
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation
Sponsor:
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Organization:
Study Overview
Official Title:
An Open-Label, Exploratory, Phase 1/2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects Without and With Heart Disease
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.
Detailed Description:
This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The first part of the study will examine control subjects, patients with very low likelihood of coronary heart disease. This initial part will determine optimal imaging procedures for studying uptake and clearance of 18F-mFBG in myocardial sympathetic neurons and provide preliminary data for estimating radiation dosimetry in adults and developing reference files for quantification of normal and abnormal levels of the radiopharmaceutical. The second part will examine a group of stable patients with New York Heart Association (NYHA) class 2 heart failure (HF) and reduced left ventricular (LV) systolic function (LV ejection fraction (EF) ≤35%). The primary objectives of the second part will be to:
* document the degree to which 18F-mFBG uptake in the heart is reduced and
* characterize the distribution of regional abnormalities in relation to findings on other cardiac imaging studies such as myocardial perfusion (MP) and magnetic resonance (MR) imaging.
Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).
* document the degree to which 18F-mFBG uptake in the heart is reduced and
* characterize the distribution of regional abnormalities in relation to findings on other cardiac imaging studies such as myocardial perfusion (MP) and magnetic resonance (MR) imaging.
Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: