[18F]-MFBG PET CT for Parkinson's (NCT06120049)
Accurately diagnose Lewy body dementia
- Trial ID
- NCT06120049
- Official Title
- Prospective Head-to-head Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT in the Differentiation Between Parkinson's Disease and Multiple System Atrophy and Between Dementia With Lewy Bodies and Alzheimer's Disease
- Goal
- Accurately diagnose Lewy body dementia
- Phase
- PHASE2, PHASE3
- Status
- RECRUITING
- Sponsor
- prof. dr. Koen Van Laere
- Study Type
- INTERVENTIONAL
- Enrollment
- 113 participants
- Conditions
- Parkinson Disease, Dementia With Lewy Bodies, MSA - Multiple System Atrophy, Alzheimer Disease
- Interventions
- [18F]-MFBG PET CT, [18F]-FE-PE2I PET CT or PET MRI, [123I]-MIBG SPECT CT, [18F]-MFBG PET dosimetry scans
Summary For Families
Researchers are testing whether a newer heart imaging method, using a tracer called 18F‑MFBG with positron emission tomography, can better detect loss of the heart's nerve supply related to the chemical norepinephrine, helping distinguish Parkinson's disease from the parkinsonian form of multiple system atrophy and dementia with Lewy bodies from Alzheimer's disease. Participants will have the 18F‑MFBG positron emission tomography scan compared directly with the standard iodine‑123 MIBG single photon emission computed tomography scan, plus a brain positron emission tomography scan that measures the dopamine transporter, so the team can compare accuracy and see if the new scan is faster, clearer, and more precise. About 113 people will be enrolled: healthy adults 18 to 85, people with Parkinson's disease or multiple system atrophy with parkinsonism aged 45 to 85, and people with probable dementia with Lewy bodies or probable Alzheimer's disease aged 50 to 85, and all will need several hospital visits for MRI and the planned scans.
Locations
- UZ Ghent, Ghent, Gent, Belgium
- UZ Leuven, Leuven, Vlaams-Brabant, Belgium
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [18F]-MFBG PET CT. Researchers are testing whether a newer heart imaging method, using a tracer called 18F‑MFBG with positron emission tomography, can better detect loss of the heart's nerve supply related to the chemical norepinephrine, helping distinguish Parkinson's disease from the parkinsonian form of multiple system atrophy and dementia with Lewy bodies from Alzheimer's disease. Participants will have the 18F‑MFBG positron emission tomography scan compared directly with the standard iodine‑123 MIBG single photon emission computed tomography scan, plus a brain positron emission tomography scan that measures the dopamine transporter, so the team can compare accuracy and see if the new scan is faster, clearer, and more precise. About 113 people will be enrolled: healthy adults 18 to 85, people with Parkinson's disease or multiple system atrophy with parkinsonism aged 45 to 85, and people with probable dementia with Lewy bodies or probable Alzheimer's disease aged 50 to 85, and all will need several hospital visits for MRI and the planned scans.
- Who can participate?
- Participants must be between 18 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 2/Phase 3 trial is estimated to last approximately 2 years and 5 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- For the main study, participants will need to visit the hospital for 3 or 4 appointments.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.