TerminatedNot Applicable

Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients

Stopped: lack of patients due to COVID

Canada18 participantsStarted 2016-10

Plain-language summary

While positron emission tomography/computed tomography (PET/CT) can assist in the diagnosis of Parkinson disease (PD), it can also potentially help monitor treatment options for PD. One such experimental therapeutic option for PD is fetal dopaminergic transplantation trials. A potential goal of such novel therapies is to replace deficient dopaminergic neurons in PD. Researchers at the University of Saskatchewan have been at the frontier of these exciting treatment options. \[18F\]FDOPA PET/CT imaging has been successfully used by some authors to monitor engraftment and assess efficacy of fetal dopaminergic transplant . This study also aims to utilize \[18F\]FDOPA PET/CT imaging to potentially aid in detecting alterations in the dopaminergic pathway from these innovative surgical treatment options. There are two main objectives of this study: 1) Evaluate the effectiveness of fetal dopaminergic grafts in patients with PD using FDOPA PET imaging pre and post-surgical implantation and a secondary longer term goal 2) Correlate the \[18F\]FDOPA PET/CT findings in early PD with post-mortem pathological analyses of PD

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Parkinson's disease based on clinical diagnosis by Neuro-surgeon and/or Neurologist with specialty in Parkinson's disease * Must be a resident of Canada * Able to understand and provide written informed consent * Referred by a treating physician * Patients must be able to tolerate the physical/logistical requirements of a FDOPA-PET/CT scan, including withholding of medication, lying supine for up to 45 minutes, and intravenous cannulation for injection of the study drug * 18 years and older, with clinical diagnosis of PD (presence of two out of following three symptoms: bradykinesia, rigidity and resting tremor) as per standard clinical practice Exclusion Criteria: * Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.) * Patients who exceed the safe weight limit of the PET/CT bed or who cannot fit through the PET/CT bore * Patients who are claustrophobic

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differences (assessed by standard uptake values (SUV)) between pre and post-surgical nigrostriatal uptake of [18F]FDOPA

Timeframe: 1-2 years

Trial details

NCT IDNCT02538315

SponsorUniversity of Saskatchewan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-09

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