Heart scan could spot Parkinson's early
NCT ID NCT07176286
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a new radioactive tracer called 18F-mFBG to see if it can detect nerve damage in the heart caused by Lewy body diseases like Parkinson's and Lewy body dementia. About 20 adults will get a PET scan after an injection of the tracer. The goal is to see if the scan can tell the difference between people with and without these diseases, which could lead to better diagnosis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Neurological Institute
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Vibrating wristband put to the test for Parkinson's relief
- Can a breathing and Nerve-Zapping combo help clear the Parkinson's brain?
- Can group brain training slow Parkinson's cognitive decline?
- Old drug showdown: can benzhexol match procyclidine for Parkinson's tremor?
- Which DBS setting works best for Parkinson's? a trial puts anodic vs cathodic to the test