[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.

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Essential Tremor
• Intervention / Treatment: Drug: SPECT; Drug: PET

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93000
    • Hopital Avicenne
  • Bordeaux, France, 33076
    • CHU Bordeaux
  • Clermont-Ferrand, France, 63000
    • Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)
  • Créteil, France, 94010
    • Hôpital Henri Mondor
  • Dijon, France, 21000
    • CLCC Georges-François Leclerc C.G.F.L
  • Lille, France, 59037
    • Hôpital Roger Salengro (CHRU de Lille)
  • Lyon, France, 69500
    • Hospices Civils de Lyon
  • Marseille, France, 13005
    • CHU La Timone
  • Nancy, France
    • Hôpital Brabois / Hôpital Central (CHRU Nancy)
  • Nantes, France, 44093
    • Hôpital Laennec (CHU Nantes)
  • Nîmes, France, 30029
    • Centre Hospitalier Universitaire de Nîmes
  • Paris, France, 75013
    • Chu La Pitie Salpetriere
  • Rennes, France, 35000
    • Centre Eugène Marquis / CHU Pontchaillou
  • Strasbourg, France, 67033
    • Institut de cancérologie Strasbourg Europe
  • Toulouse, France, 3100
    • Hôpital Pierre Paul Riquet - Purpan (CHU)
  • Tours, France, 37044
    • CHRU Hôpital Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): August 2, 2024
• Study Completion (Actual): August 2, 2024

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Essential Tremor
• Other Study ID Numbers: ZX-2018-LBT999-DATTEP-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No