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

NCT02538315 | Terminated

• 1 other identifier: Bio 15-21
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson's Disease

Keywords

[18F]FODPA, Parkinson's, PET/CT, Stem Cell transplantation

Outcome Measures

Primary Outcomes (1)

• 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

  1-2 years

Study Arms (1)

Surgery plus PET/CT imaging

Dopaminergic stem cell transplant and \[18F\]FDOPA PET/CT

Drug: [18F]FDOPA PET/CT

Interventions

[18F]FDOPA PET/CT DRUG

Implantation of fetal dopaminergic stem cell transplantation by neuro-surgeon followed by \[18F\]FDOPA PET/CT imaging

Also known as: F-18 Fluorodopa

Surgery plus PET/CT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's patients screened by Dr. I. Mendez

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• University of Manitoba: collaborator

Study Sites (1)

University Of Saskatchewan

Saskatoon, Saskatchewan, s7n 0w8, Canada

Location

Related Publications (1)

• 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.

  PMID: 19037637 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Rajan Rakheja, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 2, 2015
• Study Start: October 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CA (1)