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

Last updated: April 15, 2024
Sponsor: Zionexa
Overall Status: Active - Recruiting

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's DiseaseSociety Brain Bank (UKPDSBB)
  • Patients diagnosed over 18 months ago
  • Women of childbearing potential who must have effective contraception at baseline andup 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 3months
  • Individuals with a contraindication to PET or SPECT imaging:
  • Patients with claustrophobia
  • Patients refusing to be informed in case of abnormalities detected during imagingtests
  • 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 excipientsof the product under investigation or to the reference product or to or tothyroid treatment
  • Woman of childbearing age without effective contraception in the opinion of theinvestigator
  • Any other serious unstabilized chronic condition deemed incompatible with the study bythe 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 toenrollment 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:
December 31, 2024

Connect with a study center

  • Hôpital Avicenne

    Bobigny, 93000
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33076
    France

    Active - Recruiting

  • Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • Hôpital Henri Mondor

    Créteil, 94010
    France

    Active - Recruiting

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

    Dijon, 21000
    France

    Active - Recruiting

  • Hôpital Roger Salengro (CHRU de Lille)

    Lille, 59037
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon, 69500
    France

    Active - Recruiting

  • CHU La Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Hôpital Brabois / Hôpital Central (CHRU Nancy)

    Nancy,
    France

    Active - Recruiting

  • Hôpital Laennec (CHU Nantes)

    Nantes, 44093
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029
    France

    Active - Recruiting

  • CHU La Pitié Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • Centre Eugène Marquis / CHU Pontchaillou

    Rennes, 35000
    France

    Active - Recruiting

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033
    France

    Site Not Available

  • Hôpital Pierre Paul Riquet - Purpan (CHU)

    Toulouse, 3100
    France

    Active - Recruiting

  • CHRU Hôpital Bretonneau

    Tours, 37044
    France

    Active - Recruiting

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