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

COMPLETEDPHASE3

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

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.

NCT04265209•GE Healthcare

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

35 - 80 years

Sex

ALL

Healthy Volunteers

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
+10 more criteria

Locations (16)

Hôpital Avicenne

Bobigny, France

CHU Bordeaux

Bordeaux, France

Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

Clermont-Ferrand, France

Hôpital Henri Mondor

Créteil, France

CLCC Georges-François Leclerc C.G.F.L

Dijon, France

Hôpital Roger Salengro (CHRU de Lille)

Lille, France

Hospices Civils de Lyon

Lyon, France

CHU La Timone

Marseille, France

Hôpital Brabois / Hôpital Central (CHRU Nancy)

Nancy, France

Hôpital Laennec (CHU Nantes)

Nantes, France

Key Dates

Start Date

December 1, 2021

Primary Completion Date

August 2, 2024

Completion Date

August 2, 2024

Last Updated

November 17, 2025

Enrollment

152

ACTUAL participants

Conditions

Parkinson DiseaseEssential Tremor

Interventions

SPECT

DRUG

PET

DRUG

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations