Clinical trial NCT04265209: [18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Parkinson Disease
Essential Tremor
Lead sponsor: Zionexa
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 152
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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 diagnosed over 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

Primary outcomes:
measure: Sensitivity and specificity by visual analysis
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: CLCC Georges-François Leclerc C.G.F.L
city: Lille
country: France
facility: Hôpital Roger Salengro (CHRU de Lille)
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: CHU La Timone
city: Nancy
country: France
facility: Hôpital Brabois / Hôpital Central (CHRU Nancy)
city: Nantes
country: France
facility: Hôpital Laennec (CHU Nantes)
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Paris
country: France
facility: CHU La Pitié Salpêtrière
city: Rennes
country: France
facility: Centre Eugène Marquis / CHU Pontchaillou
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet - Purpan (CHU)
city: Tours
country: France
facility: CHRU Hôpital Bretonneau
Study officials:
References: