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18F-mFBG Imaging for Cardiovascular Disease

Phase 1 & 2

Recruiting

Led By Vikram Agarwal, MD

Research Sponsored by Illumina Radiopharmaceuticals, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 minutes after dosing

Awards & highlights

Study Summary

This trial is testing a new imaging agent to see if it can measure the amount of sympathetic nerve fibers in the heart.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests an injectable radiopharmaceutical called 18F-mFBG as an imaging tool for measuring nerve activity in the heart muscle. This early-phase trial aims to see how well it works and will involve participants receiving an injection followed by detailed heart scans.See study design

What are the potential side effects?

Possible side effects may include allergic reactions to components of the imaging agent. Since this is a Phase 1/2 study primarily focused on safety and effectiveness of the agent for imaging purposes rather than treatment-related outcomes, specific side effect profiles are being investigated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 minutes after dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 minutes after dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 minutes after dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Chang in 18F-mFBG uptake

Evaluation of 18F-mFBG for imaging myocardial sympathetic innervation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low likelihood of coronary heart diseaseExperimental Treatment1 Intervention

Thorax and total body imaging for quantification of normal biodistribution and myocardial sympathetic innervation. PET imaging to 210 minutes post-administration.

Group II: Heart Failure + left ventricular function (LVEF ≤ 35%)Experimental Treatment1 Intervention

Thorax and total body imaging for quantification of myocardial sympathetic innervation. PET imaging to 100 minutes post-administration

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Illumina Radiopharmaceuticals, LLCLead Sponsor

1 Previous Clinical Trials

43 Total Patients Enrolled

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)Lead Sponsor

2 Previous Clinical Trials

72 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiOTHER

858 Previous Clinical Trials

524,266 Total Patients Enrolled

Media Library

Heart Failure + left ventricular function (LVEF ≤ 35%) Clinical Trial Eligibility Overview. Trial Name: NCT04535193 — Phase 1 & 2

Cardiovascular Disease Research Study Groups: Heart Failure + left ventricular function (LVEF ≤ 35%), Low likelihood of coronary heart disease

Cardiovascular Disease Clinical Trial 2023: Heart Failure + left ventricular function (LVEF ≤ 35%) Highlights & Side Effects. Trial Name: NCT04535193 — Phase 1 & 2

Heart Failure + left ventricular function (LVEF ≤ 35%) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535193 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications currently being accepted for this research study?

"As indicated on clinicaltrials.gov, this research project is currently enrolling patients. The trial was first advertised on November 5th 2021 and has been updated most recently May 10th 2023."

Answered by AI

What is the participant count of this clinical research?

"Affirmative. According to clinicaltrials.gov, this trial is still actively looking for participants after first being posted on November 5th 2021 and recently updated on May 10th 2023. Approximately 20 volunteers are expected from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation

2021. "Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04535193.