Parkinson's DiseaseNCT02538315
Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients
An observational study of Parkinson's Disease, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- [18F]FDOPA PET/CT
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's patients screened by Dr. I. Mendez
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using 3,4-dihydroxy-6-[18F]-Fluoro-l-phenylalanine ( [18F]FDOPA) PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients
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
Read the detailed description
Since the progression of PD is in most cases inexorable, there is an urgent need for curative or restorative treatments, especially for patients whose response to pharmaceutical treatment is marred by levodopa-evoked dyskinesias, or intolerable on-off fluctuations. This project focuses on the option of surgical implantation of embryonic dopamine neurons. Despite promising reports in some early case studies, this daring approach has not always shown consistent clinical outcomes. The factors responsible for this state of affairs remain uncertain, although some studies showed significantly better clinical outcome in younger PD patients (≤ 60 years) as compared to older patients (≥ 60 years). In a number of small clinical studies, researchers at the University of Saskactchewan have shown one of the most consistent improvements in clinical outcomes in fetal dopaminergic grafts, as has been confirmed in a recent review of the literature. Follow-up FDOPA-PET studies have linked enhanced tracer uptake in target regions to persistent improvements in unified parkison disease rating scale (UPDRS), and FDOPA-PET is informative about the relationship between targeting of specific striatal regions and the occurrence of dyskinesias.
Co-aaplicants of this research study have received approval and funding to undertake a new clinical trial of fetal dopaminergic neurons for the treatment of advanced and otherwise refractory PD. The main objective of the present study is to correlate the clinical outcomes of PD patients who undergo fetal dopamine neuron transplantation in the new study protocol with changes in FDOPA-PET/CT. Neurologists at the University of Saskachewan and the Royal University Hospital-Saskatoon have assembled an extensive database of PD patients which have been followed prospectively for as long as a decade. As noted above, the relationship between FDOPA-PET/CT and post-mortem findings is poorly documented in small patient samples, even though autopsy findings remain the gold standard for differential diagnosis of parkinsonian syndromes, as noted above. The established reputations of these neurologists in the PD community continues to be an important prerequisite for brain banking in Saskatchewan, and an important side objective of this project is to integrate molecular imaging with prospective post mortem analysis of extensively-documented PD patients.
- Conditions
- Parkinson's Disease
- Being tested
- [18F]FDOPA PET/CT
- Keywords
- [18F]FODPA, Parkinson's, PET/CT, Stem Cell transplantation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FDOPA PET/CTDrug
Also called F-18 Fluorodopa
Implantation of fetal dopaminergic stem cell transplantation by neuro-surgeon followed by [18F]FDOPA PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus PET/CT imaging | Dopaminergic stem cell transplant and [18F]FDOPA PET/CT Receives: Drug: [18F]FDOPA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences (assessed by standard uptake values (SUV)) between pre and post-surgical nigrostriatal uptake of [18F]FDOPA
Change in the distribution of [18F]FDOPA from pre and post surgical brain scan. We are hoping to see an improvement in [18F]FDOPA in the nigrostriatal dopamine following fetal dopaminergic grafts transplant
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startOct 2016
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: lack of patients due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Principal investigator, Rajan Rakheja, University of Saskatchewan
- Investigators
- Rajan Rakheja, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538315
- Sponsor's protocol ID
- Bio 15-21
- Status last verified
- May 2023
- First submitted
- 25 Aug 2015
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Eshuis SA, Jager PL, Maguire RP, Jonkman S, Dierckx RA, Leenders KL. Direct comparison of FP-CIT SPECT and F-DOPA PET in patients with Parkinson's disease and healthy controls. Eur J Nucl Med Mol Imaging. 2009 Mar;36(3):454-62. doi: 10.1007/s00259-008-0989-5. Epub 2008 Nov 27.
PubMed 19037637
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using 3,4-dihydroxy-6-[18F]-Fluoro-l-phenylalanine ( [18F]FDOPA) PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients
- ClinicalTrials.gov ID
- NCT02538315
- Acronym / sponsor ID
- Bio 15-21
- Conditions
- Parkinson's Disease
- Keywords
- [18F]FODPA, Parkinson's, PET/CT, Stem Cell transplantation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of patients due to COVID
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Since the progression of PD is in most cases inexorable, there is an urgent need for curative or restorative treatments, especially for patients whose response to pharmaceutical treatment is marred by levodopa-evoked dyskinesias, or intolerable on-off fluctuations. This project focuses on the option of surgical implantation of embryonic dopamine neurons. Despite promising reports in some early case studies, this daring approach has not always shown consistent clinical outcomes. The factors responsible for this state of affairs remain uncertain, although some studies showed significantly better clinical outcome in younger PD patients (≤ 60 years) as compared to older patients (≥ 60 years). In a number of small clinical studies, researchers at the University of Saskactchewan have shown one of the most consistent improvements in clinical outcomes in fetal dopaminergic grafts, as has been confirmed in a recent review of the literature. Follow-up FDOPA-PET studies have linked enhanced tracer uptake in target regions to persistent improvements in unified parkison disease rating scale (UPDRS), and FDOPA-PET is informative about the relationship between targeting of specific striatal regions and the occurrence of dyskinesias.
Co-aaplicants of this research study have received approval and funding to undertake a new clinical trial of fetal dopaminergic neurons for the treatment of advanced and otherwise refractory PD. The main objective of the present study is to correlate the clinical outcomes of PD patients who undergo fetal dopamine neuron transplantation in the new study protocol with changes in FDOPA-PET/CT. Neurologists at the University of Saskachewan and the Royal University Hospital-Saskatoon have assembled an extensive database of PD patients which have been followed prospectively for as long as a decade. As noted above, the relationship between FDOPA-PET/CT and post-mortem findings is poorly documented in small patient samples, even though autopsy findings remain the gold standard for differential diagnosis of parkinsonian syndromes, as noted above. The established reputations of these neurologists in the PD community continues to be an important prerequisite for brain banking in Saskatchewan, and an important side objective of this project is to integrate molecular imaging with prospective post mortem analysis of extensively-documented PD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery plus PET/CT imaging | – | Drug: [18F]FDOPA PET/CTDopaminergic stem cell transplant and [18F]FDOPA PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients screened by Dr. I. Mendez
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FDOPA PET/CTAlso: F-18 FluorodopaImplantation of fetal dopaminergic stem cell transplantation by neuro-surgeon followed by [18F]FDOPA PET/CT imaging | Drug | Surgery plus PET/CT imaging |
Primary outcome
Differences (assessed by standard uptake values (SUV)) between pre and post-surgical nigrostriatal uptake of [18F]FDOPA
Time frame: 1-2 years
Change in the distribution of [18F]FDOPA from pre and post surgical brain scan. We are hoping to see an improvement in [18F]FDOPA in the nigrostriatal dopamine following fetal dopaminergic grafts transplant
Results and safety
The study was stopped early (reason given: lack of patients due to COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Results publication: PubMed 19037637Eshuis SA, Jager PL, Maguire RP, Jonkman S, Dierckx RA, Leenders KL. Direct comparison of FP-CIT SPECT and F-DOPA PET in patients with Parkinson's disease and healthy controls. Eur J Nucl Med Mol Imaging. 2009 Mar;36(3):454-62. doi: 10.1007/s00259-008-0989-5. Epub 2008 Nov 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajan Rakheja, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of patients due to COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences (assessed by standard uptake values (SUV)) between pre and post-surgical nigrostriatal uptake of [18F]FDOPA (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02538315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.