18F-mFBG Imaging for Lewy Body Dementia
(IRP101-231 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants receive an intravenous injection of 18F-mFBG followed by whole-body imaging and static thorax imaging
Follow-up
Participants are monitored for safety and effectiveness after imaging
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
All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes.
All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Lead Sponsor
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 ...
[ 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 ...
4.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT07176286/18f-mfbg-cardiac-uptake-with-lewy-body-dementia18F-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 ...
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