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

Parkinson Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265209
• Other study ID #: ZX-2018-LBT999-DATTEP-3
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Zionexa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Tremor

Intervention

Drug:
• SPECT
[123I]-FP-CIT SPECT imaging procedure
• PET
[18F] LBT-999 PET imaging procedure

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Zionexa

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity by visual analysis	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.	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.