[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor

Study Overview
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Brief Summary
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Clinical study to demonstrate an at least equivalent performance of a new PET molecular Imaging radiopharmaceutical named [18F] LBT-999 in brain imaging compared to the SPECT reference method named [123I]-FP-CIT to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.

Official Title
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Non-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor.

Conditions
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Parkinson Disease, Essential Tremor

Intervention / Treatment
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* Drug: SPECT
* Drug: PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patient with atypical non-idiopathic parkinsonian syndrome Patient treated with deep brain stimulation Patient treated with invasive brain surgery (gamma knife, ultrasound, etc) Patient suffering with 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: Patient with claustrophobia Patient refusing to be informed in case of abnormalities detected during imaging examinations Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline 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: Pregnant or lactating woman Person deprived of liberty by a judicial or administrative decision, Person under psychiatric care Person admitted to a health or social institution for purposes other than research Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice) Major person unable to express consent and who is not subject to a legal protection measure

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SPECT and PET<br>[123I]-FP-CIT SPECT imaging procedure first, then [18F] LBT-999 PET Imaging procedure | Drug: SPECT<br>* [123I]-FP-CIT SPECT imaging procedure<br>Drug: PET<br>* [18F] LBT-999 PET imaging procedure<br>|
| Other: PET and SPECT<br>[18F] LBT-999 PET imaging procedure first, then [123I]-FP-CIT SPECT imaging procedure | Drug: SPECT<br>* [123I]-FP-CIT SPECT imaging procedure<br>Drug: PET<br>* [18F] LBT-999 PET imaging procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity by visual analysis | 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. | The independent review committee will analyse the PET and SPECT images blindly. These analyses will be done by batch of 25 patients. Outcome will be assessed at the end of the study, an average of 2 years after first patient in. |