[¹⁸F]MODAG-009 PET Imaging for Parkinson's (NCT07617688)
Test imaging tracer for Parkinson
- Trial ID
- NCT07617688
- Official Title
- Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers
- Goal
- Test imaging tracer for Parkinson
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- MODAG GmbH
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Healthy Adult
- Interventions
- [¹⁸F]MODAG-009 PET Imaging
Summary For Families
The goal is to learn how a new PET imaging tracer behaves in the body and how much radiation it gives, as a first safety step toward using it for brain imaging related to Parkinson’s research. Participants receive a tiny dose of [18F]MODAG-009, a small molecule labeled with fluorine-18 that emits positrons so the PET camera can map where the tracer goes, how quickly it clears, and how much each organ absorbs; it is an imaging agent, not a treatment, and it does not affect levodopa. Scans and blood tests let investigators calculate pharmacokinetics, organ uptake, and radiation dosimetry to guide safe use in future studies. Healthy adults 18 to 60 who can consent are eligible, but people who are pregnant or breastfeeding, on recent medications, with significant medical issues, recent heavy radiation exposure, recent tobacco use, or recent large blood loss are excluded.
Locations
- Institute for Neurodegenerative Disorders and XingImaging, LLC, New Haven, Connecticut, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [¹⁸F]MODAG-009 PET Imaging. The goal is to learn how a new PET imaging tracer behaves in the body and how much radiation it gives, as a first safety step toward using it for brain imaging related to Parkinson’s research. Participants receive a tiny dose of [18F]MODAG-009, a small molecule labeled with fluorine-18 that emits positrons so the PET camera can map where the tracer goes, how quickly it clears, and how much each organ absorbs; it is an imaging agent, not a treatment, and it does not affect levodopa. Scans and blood tests let investigators calculate pharmacokinetics, organ uptake, and radiation dosimetry to guide safe use in future studies. Healthy adults 18 to 60 who can consent are eligible, but people who are pregnant or breastfeeding, on recent medications, with significant medical issues, recent heavy radiation exposure, recent tobacco use, or recent large blood loss are excluded.
- Who can participate?
- Participants must be between 18 Years and 60 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Participants will have up to 3 imaging sessions on the imaging day lasting up to 6 hours after injection, plus a follow-up contact 7 (+/-2) business days after injection.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Intravenous infusion (minimally invasive); Injection (minimally invasive); Heart tracing (ECG) (non-invasive). Confirm the full schedule with the study coordinator.