18F-mFBG PET imaging of heart nerve uptake in Lewy body dementia and Parkinson disease.

An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With and Without Lewy Body Diseases

This study will test whether the PET tracer 18F-mFBG can measure loss of heart sympathetic nerve function in people with Lewy body dementia or Parkinson disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07176286 on ClinicalTrials.gov

What this trial studies

This Phase 2, single-site study uses the PET radiotracer 18F-mFBG to quantify myocardial sympathetic innervation in adults with Lewy body disease and in a comparison group with non-Lewy neurological diseases. Clinically stable participants will receive 18F-mFBG and undergo cardiac PET imaging to measure myocardial uptake and clearance parameters. Results from Lewy body and non-Lewy cohorts will be compared with each other and with historical healthy-control data to identify quantitative differences in tracer uptake. The protocol aims to provide more standardized and higher-resolution quantitative measures than traditional 123I-mIBG SPECT methods.

Who should consider this trial

Good fit: Adults aged 18 or older who are clinically stable, can consent, and have a diagnosis of Parkinson disease or dementia with Lewy bodies (or a non-Lewy neurodegenerative comparator) and can undergo PET imaging are ideal candidates.

Not a fit: People with unstable medical conditions, contraindications to PET/radiotracer exposure, or cardiac conditions that would confound myocardial uptake measurements may not receive diagnostic benefit from this imaging.

Why it matters

Potential benefit: If successful, 18F-mFBG PET could provide a standardized, more quantitative way to detect cardiac sympathetic nerve loss and help with diagnosis or tracking of Lewy body diseases.

How similar studies have performed: Previous work using 123I-mIBG SPECT has consistently shown reduced myocardial uptake in Lewy body disease with high sensitivity and specificity, while 18F-mFBG PET is a newer approach intended to improve quantitation and standardization.

Eligibility criteria

Inclusion Criteria:

* 1\. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.

  3\. A male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.

  4\. All subjects: Judged clinically stable for at least 30 days before enrolment into the study and remains stable to the time of the study imaging procedure.

For Lewy body disease subjects (Study Cohort I):

5\. The subject has a diagnosis of either PD or DLB based on accepted clinical criteria at least 6 months before enrollment into the study.

For non-Lewy body disease subjects (Study Cohort II):

6\. The subject has a diagnosis of neurological or neurodegenerative disease for which neither PD nor DLB is judged likely by a neurologist based on accepted clinical and imaging criteria.

Exclusion Criteria:

* 1\. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.

  2\. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.

  3\. Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.

  4\. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.

  5\. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.

  6\. The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes.

  7\. Renal insufficiency (serum creatinine \>3.0 mg/dL). 8. Uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.

  9\. Participated in a research study using ionizing radiation in the previous 12 months such that participation in the study might result in a total effective dose from research procedures exceeding 50 milliSieverts during that time interval.

Where this trial is running

Houston, Texas

• Houston Methodist Neurological Institute — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Juan B Toledo, MD — The Methodist Hospital Research Institute
• Study coordinator: Research Coordinator

Conditions Parkinson Disease; Lewy Body Dementia; IRP101-231; 18F-mFBG