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

NCT04265209 | Completed Phase 3 DMC

• 1 other identifier: ZX-2018-LBT999-DATTEP-3
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Parkinson Disease; Essential Tremor

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

SPECT and PET

OTHER

\[123I\]-FP-CIT SPECT imaging procedure first, then \[18F\] LBT-999 PET Imaging procedure

Drug: SPECT; Drug: PET

PET and SPECT

OTHER

\[18F\] LBT-999 PET imaging procedure first, then \[123I\]-FP-CIT SPECT imaging procedure

Drug: SPECT; Drug: PET

Interventions

SPECT DRUG

\[123I\]-FP-CIT SPECT imaging procedure

PET and SPECT; SPECT and PET

PET DRUG

\[18F\] LBT-999 PET imaging procedure

PET and SPECT; SPECT and PET

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (16)

Hôpital Avicenne

Bobigny, 93000, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

Clermont-Ferrand, 63000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CLCC Georges-François Leclerc C.G.F.L

Dijon, 21000, France

Location

Hôpital Roger Salengro (CHRU de Lille)

Lille, 59037, France

Location

Hospices Civils de Lyon

Lyon, 69500, France

Location

CHU La Timone

Marseille, 13005, France

Location

Hôpital Brabois / Hôpital Central (CHRU Nancy)

Nancy, France

Location

Hôpital Laennec (CHU Nantes)

Nantes, 44093, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

CHU La Pitié Salpêtrière

Paris, 75013, France

Location

Centre Eugène Marquis / CHU Pontchaillou

Rennes, 35000, France

Location

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

Hôpital Pierre Paul Riquet - Purpan (CHU)

Toulouse, 3100, France

Location

CHRU Hôpital Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 11, 2020
• Study Start: December 1, 2021
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (16)