- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02538315
Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients
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
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 0W8
- University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgery plus PET/CT imaging
Dopaminergic stem cell transplant and [18F]FDOPA PET/CT
|
Implantation of fetal dopaminergic stem cell transplantation by neuro-surgeon followed by [18F]FDOPA PET/CT imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1-2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rajan Rakheja, MD, University of Saskatchewan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bio 15-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
AbbVieActive, not recruitingParkinson's Disease (PD)United States, Australia
-
AbbVieCompletedParkinson's Disease (PD)United States, Australia
-
BlueRock TherapeuticsMemorial Sloan Kettering Cancer CenterActive, not recruitingAdvanced Parkinson's DiseaseUnited States, Canada
Clinical Trials on [18F]FDOPA PET/CT
-
The Methodist Hospital Research InstituteUniversity of California, Los AngelesTerminatedGlioma | Glioblastoma | Glioblastoma MultiformeUnited States
-
Assistance Publique Hopitaux De MarseilleCompletedMetastatic MelanomaFrance
-
Centre Antoine LacassagneCompleted
-
Jonsson Comprehensive Cancer CenterKaiser Permanente; The Methodist Hospital Research InstituteCompletedGlioma | GlioblastomaUnited States
-
Asan Medical CenterTerminatedPheochromocytoma | ParagangliomaKorea, Republic of
-
Erik MittraNational Cancer Institute (NCI)TerminatedUntreated Childhood Brain Stem Glioma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Oligodendroglioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma and other conditionsUnited States
-
Wuxi No. 4 People's HospitalUnknownCarcinoma, Bronchogenic | Lymphoma, Malignant | Breast Carcinoma | Cancer of Head and Neck | Soft Tissue Neoplasms | TumorsChina
-
British Columbia Cancer AgencyNo longer availableThyroid Cancer, Medullary | Neuroblastoma | Pheochromocytoma | Carcinoid Tumor | Paraganglioma | InsulinomaCanada
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)TerminatedProstate CancerUnited States
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonNot yet recruitingCancer | Diagnosis | Resistant Cancer | Response, Acute Phase