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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 11 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.