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

Last updated: November 14, 2025
Sponsor: GE Healthcare
Overall Status: Completed

Phase

3

Condition

Essential Tremor

Dystonia

Treatment

PET

SPECT

Clinical Study ID

NCT04265209
ZX-2018-LBT999-DATTEP-3
  • Ages 35-80
  • All Genders

Study 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 Criteria

Inclusion

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 theinvestigator)

  • or with Parkinson's disease as defined by the United Kingdom Parkinson'sDisease Society Brain Bank (UKPDSBB)

  • Patients with clinical symptoms dated more than 18 months ago

  • Women of childbearing potential who must have effective contraception at baselineand 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 whohave signed their informed consent

Exclusion

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 withimaging 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 duringimaging 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 theexcipients of the product under investigation or to the reference product or toor to thyroid treatment

  • Woman of childbearing age without effective contraception in the opinion of theinvestigator

  • Any other serious unstabilized chronic condition deemed incompatible with the studyby 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 priorto enrollment in clinical studies

  • Patients in a period of exclusion from the national volunteer database during whichthey 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 FrenchPublic Health Code

Study Design

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: PET
Phase: 3
Study Start date:
December 01, 2021
Estimated Completion Date:
August 02, 2024

Connect with a study center

  • Hôpital Avicenne

    Bobigny, 93000
    France

    Site Not Available

  • Hôpital Avicenne

    Bobigny 3032179, 93000
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33076
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux 3031582, 33076
    France

    Site Not Available

  • Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

    Clermont-Ferrand 3024635, 63000
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil, 94010
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil 3022530, 94010
    France

    Site Not Available

  • CLCC Georges-François Leclerc C.G.F.L

    Dijon, 21000
    France

    Site Not Available

  • CLCC Georges-François Leclerc C.G.F.L

    Dijon 3021372, 21000
    France

    Site Not Available

  • Hôpital Roger Salengro (CHRU de Lille)

    Lille, 59037
    France

    Site Not Available

  • Hôpital Roger Salengro (CHRU de Lille)

    Lille 2998324, 59037
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon, 69500
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon 2996944, 69500
    France

    Site Not Available

  • CHU La Timone

    Marseille, 13005
    France

    Site Not Available

  • CHU La Timone

    Marseille 2995469, 13005
    France

    Site Not Available

  • Hôpital Brabois / Hôpital Central (CHRU Nancy)

    Nancy,
    France

    Site Not Available

  • Hôpital Brabois / Hôpital Central (CHRU Nancy)

    Nancy 2990999,
    France

    Site Not Available

  • Hôpital Laennec (CHU Nantes)

    Nantes, 44093
    France

    Site Not Available

  • Hôpital Laennec (CHU Nantes)

    Nantes 2990969, 44093
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes 2990363, 30029
    France

    Site Not Available

  • CHU La Pitié Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • CHU La Pitié Salpêtrière

    Paris 2988507, 75013
    France

    Site Not Available

  • Centre Eugène Marquis / CHU Pontchaillou

    Rennes, 35000
    France

    Site Not Available

  • Centre Eugène Marquis / CHU Pontchaillou

    Rennes 2983990, 35000
    France

    Site Not Available

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033
    France

    Site Not Available

  • Institut de cancérologie Strasbourg Europe

    Strasbourg 2973783, 67033
    France

    Site Not Available

  • Hôpital Pierre Paul Riquet - Purpan (CHU)

    Toulouse, 3100
    France

    Site Not Available

  • Hôpital Pierre Paul Riquet - Purpan (CHU)

    Toulouse 2972315, 3100
    France

    Site Not Available

  • CHRU Hôpital Bretonneau

    Tours, 37044
    France

    Site Not Available

  • CHRU Hôpital Bretonneau

    Tours 2972191, 37044
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.