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

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ClinicalTrials.gov Identifier: NCT04265209
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Zionexa

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Essential Tremor Drug: SPECT Drug: PET Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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.
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Sensitivity and specificity by visual analysis [ Time Frame: 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient:

    • suffering from an essential tremor according to the 2000 criteria of Elble (excluding head's tremor)
    • or with Parkinson's disease according to UKPDSBB criteria
  • Patient whose diagnosis is more than 18 months old
  • Patient affiliated with a health protection system or beneficiary of such a system
  • Patient who has received complete information on the organization of the research and signed his informed consent

Exclusion Criteria:

  • Patient with atypical non-idiopathic parkinsonian syndrome
  • Patient treated with deep brain stimulation
  • Patient suffering from abnormal functional psychogenic movements
  • Patient with severe and progressive psychiatric disorders
  • Patient with disabling dyskinesia or essential tremor, incompatible with performing imaging exams
  • Patient who had an ionizing examination at the cerebral level less than 3 months old
  • Person with a contraindication to performing PET or SPECT imaging:

    • Patient with claustrophobia
    • Patient refusing to be informed in case of abnormalities detected during imaging examinations
    • Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
    • Person with a known allergy to the active substance or to any of the excipients of the evaluated product or reference product or to potassium iodide
  • A woman of childbearing potential who does not have effective contraception according to investigator judgment
  • Patient unable to sign the informed consent
  • Patient participating to a protocol or period of exclusion from a protocol
  • Patient who received benefits over € 4,500 in the last 12 months prior to inclusion in clinical studies
  • Patient in exclusion period in national volunteer file during which he can not participate in another clinical study
  • Patient not affiliated to a health protection system
  • Patient refusing to participate
  • Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code:

    • Pregnant or lactating woman
    • Person deprived of liberty by a judicial or administrative decision,
    • Person under psychiatric care
    • Person admitted to a health or social institution for purposes other than research
    • Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice)
    • Major person unable to express consent and who is not subject to a legal protection measure

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Responsible Party: Zionexa
ClinicalTrials.gov Identifier: NCT04265209    
Other Study ID Numbers: ZX-2018-LBT999-DATTEP-3
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms