Patients suffering from an essential tremor or with Parkinson's disease. MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10015496 Term: Essential tremor System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: DaTSCAN 74 MBq/ml solution for injection
Pharmaceutical Form: Solution for injection
Product Code: [18F] LBT-999
Pharmaceutical Form: Solution for injection
Sponsors
ZIONEXA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient aged 35 to 80 (male or female) • Patient: - suffering from an essential tremor according to the 2000 criteria of Elble (excluding head's tremor) - or with Parkinson's disease according to UKPDSBB criteria • Patient whose diagnosis is more than 18 months old • Patient affiliated with a health protection system or beneficiary of such a system • Patient who has received complete information on the organization of the research and signed his informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient with atypical non-idiopathic parkinsonian syndrome (multisystematous atrophy, progressive supranuclear palsy, etc.) • Patient treated with deep brain stimulation • Patient suffering from abnormal functional psychogenic movements • Patient with severe and progressive psychiatric disorders • Patient with disabling dyskinesia or essential tremor, incompatible with performing imaging exams • Patient who had an ionizing examination at the cerebral level less than 3 months old • Person with a contraindication to performing PET or SPECT imaging: o Patient with claustrophobia o Patient refusing to be informed in case of abnormalities detected during imaging examinations o Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline o Person with a known allergy to the active substance or to any of the excipients of the evaluated product or reference product or to potassium iodide • A woman of childbearing potential who does not have effective contraception according to investigator judgment • Patient unable to sign the informed consent • Patient participating to a protocol or period of exclusion from a protocol • Patient who received benefits over € 4,500 in the last 12 months prior to inclusion in clinical studies • Patient in exclusion period in national volunteer file during which he can not participate in another clinical study • Patient not affiliated to a health protection system • Patient refusing to participate • Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code: o Pregnant or lactating woman o Person deprived of liberty by a judicial or administrative decision, o Person under psychiatric care o Person admitted to a health or social institution for purposes other than research o Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice) o Major person unable to express consent and who is not subject to a legal protection measure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate an at least equivalent performance of [18F] LBT-999-PET with respect to [123I]-FP-CIT-SPECT in visual analysis for the differential diagnosis of patients suffering of Essential Tremor or Parkinson’s Disease (visual/qualitative analysis);Secondary Objective: Calculate the threshold value with [18F] LBT-999-PET (in quantitative analysis) that best distinguish Parkinson’s Disease from Essential Tremor - Show that when using the [18F] LBT-999-PET compared with [123I]-FP-CIT-SPECT, these are achieved: (i) Improvement of patient’s comfort during image acquisition (ii) Improvement of confidence level during image interpretation (iii) Equivalent performance of [18F] LBT-999-PET with respect to [123I]-FP/CIT-SPECT for the differential diagnosis of patients suffering of Essential Tremor or Parkinson’s Disease (quantitative analysis) (iv) Improvement of the precision of quantification - Evaluate patient tolerance to [18F] LBT-999 - Dosimetry evaluations for patients and caregivers;Primary end point(s): Sensitivity and specificity of each imaging method on the diagnosis of normal or pathological examination on the visual analysis by 5 independent readers interpreting a minimum of 200 [123I]-FP/CIT-SPECT per year, without knowing the clinical diagnosis;Timepoint(s) of evaluation of this end point: The independent review committee will analyse the PET and TEMP images blindly. These analyses will be done by batch of 25 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - [18F] LBT-999-PET threshold for distinguishing Parkinson’s Disease from Essential Tremor - (i) Patient’s comfort will be measured using the visual analogic scale for each type of image acquisition (i.e. PET and SPECT), except for patient with entire body dosimetry - (ii) Diagnostic confidence in the interpretation of MRP fixation for the caudate nuclei and putamens of each patient for each type of examination (SPECT and PET). This trust will be assessed by each reviewer using criteria scales on image quality and interpretation trust (Poor, moderate, almost perfect) - (iii) Sensitivity and specificity of each diagnostic method of examination by quantified analysis - (iv) Precision of quantification for each method of image acquisition - Adverse events during image acquisition - Dosimetry measurements for [18F] LBT-999 patients and their caregivers;Timepoint(s) of evaluation of this end point: Data collected during V1 and V2 visits (SPECT/PET). | — |
Countries
France
Contacts
Public ContactAmandine COCHE
ZIONEXA
Outcome results
None listed