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.

ZX-2018-LBT999-DATTEP-3

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.

2021-12-01

2024-09-01

2024-12-01

Recruiting

Early phase I

152

Inclusion Criteria: * Patients aged 35 to 80 (male or female) * Patients: * suffering from an essential tremor as defined by Elble's criteria from 2000 (excluding head tremor in decubitus and compatible with the study by the investigator) * or with Parkinson's disease as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) * Patients diagnosed over 18 months ago * Women of childbearing potential who must have effective contraception at baseline and up to 30 days after the last administration of the radiopharmaceutical (investigational medicinal product or comparator) * Patients affiliated with or receiving a social security scheme * Patients who have been fully informed about the organization of the research and who have signed their informed consent Exclusion Criteria: * Patients with atypical non-idiopathic Parkinson's syndrome (multi system atrophy, progressive supranuclear palsy, etc.) * Patients treated with deep brain stimulation * Patients with functional psychogenic movements * Patients with severe and progressive psychiatric disorders * Patients with disabling dyskinesia or essential tremor that are incompatible with imaging studies * Patients who have had an ionizing radiation examination on the brain within the last 3 months * Individuals with a contraindication to PET or SPECT imaging: * Patients with claustrophobia * Patients refusing to be informed in case of abnormalities detected during imaging tests * Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline * Individuals with a known allergy to the active substance or one of the excipients of the product under investigation or to the reference product or to or to thyroid treatment * Woman of childbearing age without effective contraception in the opinion of the investigator * Any other serious unstabilized chronic condition deemed incompatible with the study by the investigator * Patients unable to sign the informed consent * Patients participating in a protocol or in a period of exclusion from a protocol * Patients who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies * Patients in a period of exclusion from the national volunteer database during which they cannot participate in another clinical study * Patients not affiliated with a social security scheme * Patients refusing to participate * Individuals referred to in articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 152, 'type': 'ESTIMATED'}}

2024-04-16