Recruiting
Phase 2

18F-mFBG

Sponsor:

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Code:

NCT07176286

Conditions

Parkinson Disease (PD)

Lewy Body Dementia (LBD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-MFBG

Study Details

Brief summary:

This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.

Conditions

Parkinson Disease (PD)

Lewy Body Dementia (LBD)

Study ID

NCT07176286

Start date

Apr 30, 2026

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)

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.

active comparator: Cohort 2: neurologic disease due to non-Lewy body pathology.

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.

Interventions

18F-MFBG

Intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG followed by whole body PET imaging.

Primary outcome measure

  • Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)). [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Houston Methodist Neurological Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • IRP101-231
  • 18F-mFBG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) on 2026-07-01.