20 Participants NeededMy employer runs this trial

18F-mFBG Imaging for Lewy Body Dementia

(IRP101-231 Trial)

RC
CT
Overseen ByClinical Trials Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method called 18F-mFBG, a radiotracer used in PET scans, to assess its effectiveness in detecting heart damage caused by neurodegenerative diseases like Parkinson's disease and Lewy body dementia. The researchers aim to compare these images with those of individuals with other neurologic diseases and healthy individuals. Participants should have either Parkinson's, Lewy body dementia, or a different neurologic condition unrelated to these diseases. As a Phase 2 trial, this research measures the imaging method's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in diagnostic imaging.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications that interfere with the study's imaging agent, but only if they can be safely withheld 24 hours before the study procedures. It's best to discuss your specific medications with the study team.

What prior data suggests that 18F-mFBG is safe for imaging in humans?

Studies have shown that 18F-mFBG is a safe and effective imaging agent. Research indicates that patients tolerate it well during PET scans, which assess heart function. Previous studies have reported no major safety concerns. This evidence suggests that 18F-mFBG is a safe and practical choice for heart imaging, especially for individuals with conditions like Lewy body dementia.12345

Why are researchers excited about this trial?

Unlike the standard treatments for Lewy body dementia, which often focus on managing symptoms with medications like cholinesterase inhibitors and levodopa, 18F-mFBG imaging offers a novel diagnostic approach. This technique employs a radioactive tracer, 18F-mFBG, to capture detailed images of the nervous system, potentially enhancing the detection and understanding of Lewy body pathology. Researchers are excited because this imaging could lead to earlier and more accurate diagnosis, improving how we manage and treat these conditions in the future.

What evidence suggests that 18F-mFBG imaging is effective for Lewy body dementia?

Research has shown that 18F-mFBG effectively aids heart imaging to assess neurodegenerative diseases like Lewy body dementia. In this trial, participants will receive an intravenous injection of 18F-mFBG, followed by whole-body imaging. Studies have demonstrated that 18F-mFBG PET/CT scans can distinguish between Lewy body disease and other neurological conditions by examining the heart's nerve supply. This imaging method offers advantages over older techniques, such as [123I]MIBG scintigraphy, used for similar purposes. Identifying differences in heart imaging helps doctors better understand and diagnose conditions like Parkinson’s disease and Lewy body dementia. Early findings suggest that this new imaging agent could improve the accuracy of diagnosing these diseases.12367

Who Is on the Research Team?

JB

Juan B Toledo, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who have been diagnosed with Parkinson's disease, Lewy body dementia, or another neurological condition. Participants must be clinically stable and able to follow study procedures. Women of childbearing age need a negative pregnancy test.

Inclusion Criteria

I am 18 or older and agree to follow the study rules.
I am not pregnant, and I cannot become pregnant due to surgery, menopause, or I am using birth control.
I have a neurological condition that is not Parkinson's or dementia with Lewy bodies.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive an intravenous injection of 18F-mFBG followed by whole-body imaging and static thorax imaging

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-MFBG

Trial Overview

The study tests the imaging agent 18F-mFBG to see how well it can detect changes in heart nerves caused by neurodegenerative diseases like Parkinson's and Lewy body dementia using PET scans.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)Active Control1 Intervention
Group II: Cohort 2: neurologic disease due to non-Lewy body pathology.Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Lead Sponsor

Trials
3
Recruited
60+

Citations

18F-mFBG Cardiac Uptake With Lewy Body Dementia

Effectiveness of 18F-mFBG imaging ... Neurologists and movement disorder specialists find mIBG imaging helpful for assessing suspected Lewy body disease.

Evaluating the Efficacy of 18F-MFBG PET/CT in Differentiating ...

Conclusions: 18F-MFBG PET/CT is an effective imaging modality for assessing myocardial sympathetic innervation, facilitating the differential ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40924149/

[ 18 F]MFBG PET/CT imaging of myocardial sympathetic ...

Recently, meta-[18F] fluorobenzylguanidine ([18F]MFBG) PET demonstrated favorable imaging characteristics compared with [123I]MIBG scintigraphy for ...

18F-mFBG Cardiac Uptake With Lewy Body Dementia

Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy ...

[F]MFBG PET/CT imaging of myocardial sympathetic ...

Methods For dosimetry, three controls underwent sequential whole-body [18F]MFBG PET/CT up to 6 hours postinjection. Five controls and three PD ...

MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA ...

Study goal: The goal of this prospective head to head comparison is to evaluate the effectiveness of [18F]-MFBG PET in assessing cardiac innervation, ...

[18F]-MFBG PET of the cardiac noradrenergic system for ...

The main aim of this project is to validate and optimize the clinical use, leading to reimbursement of recently introduced cardiac [18F]-MFBG noradrenergic ...