18F-mFBG Imaging for Cardiovascular Disease
Trial Summary
What is the purpose of this trial?
This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that interfere with NET-dependent agents at least 24 hours before the study procedures.
What data supports the effectiveness of the drug 18F-mFBG for cardiovascular disease?
How does the drug 18F-mFBG differ from other treatments for cardiovascular disease?
18F-mFBG is a novel imaging agent that offers higher spatial resolution and sensitivity compared to the traditional [123I]mIBG imaging used for assessing heart conditions. This makes it potentially more effective in identifying ischemic and viable heart tissue, which can improve diagnosis and treatment planning for cardiovascular diseases.46789
Research Team
Vikram Agarwal, MD
Principal Investigator
Mount Sinai Morningside
Eligibility Criteria
This trial is for adults who can follow the study procedures and have signed a consent form. It's open to those who are sterile, postmenopausal, not breastfeeding, or if of childbearing potential, not pregnant. People with recent heart procedures, serious allergies to the imaging agent, certain pacemakers, high plasma catecholamines due to non-cardiac conditions like pheochromocytoma, claustrophobia preventing stillness during scans, severe kidney issues or on interfering medications cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging Procedure - Control Group
Control subjects with low likelihood of coronary heart disease undergo thorax and total body imaging for quantification of myocardial sympathetic innervation.
Imaging Procedure - Heart Failure Group
Patients with NYHA class 2 heart failure and reduced LV systolic function undergo thorax and total body imaging for quantification of myocardial sympathetic innervation.
Follow-up
Participants are monitored for safety and effectiveness after imaging procedures
Treatment Details
Interventions
- 18F-mFBG
Find a Clinic Near You
Who Is Running the Clinical Trial?
Illumina Radiopharmaceuticals, LLC
Lead Sponsor
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Lead Sponsor
Mount Sinai Hospital, New York
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator