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

NCT ID: NCT04265209

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-08-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

SPECT and PET

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

Group Type: OTHER

SPECT

Intervention Type: DRUG

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

PET

Intervention Type: DRUG

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

PET and SPECT

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

Group Type: OTHER

SPECT

Intervention Type: DRUG

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

PET

Intervention Type: DRUG

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

Interventions

SPECT

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

Intervention Type: DRUG

PET

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

CHU La Pitié Salpêtrière

Paris, , France

Centre Eugène Marquis / CHU Pontchaillou

Rennes, , France

Institut de cancérologie Strasbourg Europe

Strasbourg, , France

Hôpital Pierre Paul Riquet - Purpan (CHU)

Toulouse, , France

CHRU Hôpital Bretonneau

Tours, , France

Countries

France

Other Identifiers

ZX-2018-LBT999-DATTEP-3

Identifier Type: -

Identifier Source: org_study_id