Patients with newly clinically diagnosed untreated idiopathic parkinsonism MedDRA version: 20.0 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism System Organ Class: 100000004852
Conditions
Interventions
Product Name: [18F]FE-PE2I
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane
Current Sponsor code: [
Sponsors
Umeå University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients -Woman or man, age 45-80 years who has given written informed consent to participate in the study - For a woman in childbearing age: Negative pregnancy test in connection with inclusion and consent to the use of effective contraception (the so-called Pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: Principal exclusion criteria (list the most important, max 5000 characters) -Severe ongoing medical condition that can be predicted to impair full participation in the study (e.g. treatment of cancer) - Disease which prevents imaging (eg PET/CT, SPECT and MR) in prone position (e.g. severe heart failure, severe backache) - History of stroke, TIA or known other serious neurological / neurodegenerative disorders (e.g., brain tumor, multiple sclerosis, ALS) - Secondary parkinsonism (e.g. drug-induced Parkinsonism or obvious vascular parkinsonism) -Known hypersensitivity to iodine -Claustrophobia or other contraindication for MRI (e.g pacemaker or magnetic implant etc) -Depression or other severe psychiatric condition in need of treatment (psychosis or similar severity) -Dementia or MMSE 180/110 mmHg) -History of drug abuse (e.g. central stimulants or alcohol; nicotine use excepted) -Pregnancy or breast-feeding -Not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic potential of [18F] FE PE2I PET in early untreated parkinsonian disease To "head-to-head" compare the diagnostic accuracy of the index test (with [18F] FE PE2I PET / CT) with the reference test (123I-FP-Cit, DaTSCAN ™ SPECT/CT) in newly onset idiopathic parkinsonism ;Secondary Objective: -To assess whether the initial dynamic phase (K1) at [18F] FE PE2I PET / CT can be used to assess rCBF -To Investigate whether polymorphisms in the DAT-1 gene affects the BPND (and possibly the relative specific uptake) of 18F FE PE2I -To Investigate the relationship between BPND (and possibly the relative specific uptake) of [18F] FE PE2I and clinical parameters, and to assess the relationship between BPND of [18F] FE PE2I and structural and functional MRI in relevant brain areas -To evaluate scanning protocols, dosing and image reconstruction methods for [18F] FE PE2I PET / CT -To analyze safety parameters at 18F PE2I PET / CT ;Primary end point(s): -Sensitivity, specificity and predictive value of PET / CT with 18F FE PE2I in the striatum and extrastriatalt in the brain -Statistical difference in the sensitivity and specificity of PET / CT with 18F FE PE2I (Index test) compared to SPECT / CT imaging with 123I-FP-Cit (reference test);Timepoint(s) of evaluation of this end point: The final calculation of the primary outcome measurements can be made after the clinical follow-up, two years after the imaging, when the clinical diagnosis is reassessed (gold standard in this study). An interim preliminary calculation may be done after the participants have completed [18F] FE PE2I PET/CT (index test) and 123I-FP-Cit SPECT / CT imaging (reference test) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Statistical correlation between the initial dynamic phase (K1) of [18F] FE PE2I PET / CT and 15O H2O PET / CT - Statistical relationship between BPND (and relative specific uptake) of [18F] FE PE2I in the presence of 9R or 10R-alleles of the DAT1 gene (SLC6A3) respectively - Statistical correlation between BPND (and relative specific uptake) of [18F] FE PE2I and UPDRS-III, H & Y, age and gender - Statistical correlation between [18F] FE PE2I PET / CT and MRI in the relevant brain areas - Adequate dosing and scanning procedure - Effective radiation dose - Adverse events ;Timepoint(s) of evaluation of this end point: The final calculation of the secondary outcome measurements may be made after the participants have completed [18F] FE PE2I PET/CT | — |
Countries
Sweden
Contacts
Public ContactSusanna Jakobson Mo
Umeå University Hospital
Outcome results
None listed