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.

Trial ID: NCT04265209

Interventional - Phase 3 - Completed

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.

Conditions

• Parkinson Disease
• Essential Tremor

Interventions

• SPECT
• PET

Eligibility

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 with clinical symptoms dated more than 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

Sponsor

GE Healthcare

Source: ClinicalTrials.gov

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