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

Phase 3

Recruiting

• Conditions: Parkinson Disease; Essential Tremor
• Interventions: Drug: SPECT; Drug: PET

• Registration Number: NCT04265209
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2021-12-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPECT and PET	SPECT	\[123I\]-FP-CIT SPECT imaging procedure first, then \[18F\] LBT-999 PET Imaging procedure
SPECT and PET	PET	\[123I\]-FP-CIT SPECT imaging procedure first, then \[18F\] LBT-999 PET Imaging procedure
PET and SPECT	SPECT	\[18F\] LBT-999 PET imaging procedure first, then \[123I\]-FP-CIT SPECT imaging procedure
PET and SPECT	PET	\[18F\] LBT-999 PET imaging procedure first, then \[123I\]-FP-CIT SPECT imaging procedure

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity by visual analysis	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.

Trial Locations

Locations (16)

Hôpital Avicenne; 🇫🇷 Bobigny, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CLCC Georges-François Leclerc C.G.F.L; 🇫🇷 Dijon, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Eugène Marquis / CHU Pontchaillou; 🇫🇷 Rennes, France

Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU); 🇫🇷 Clermont-Ferrand, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Roger Salengro (CHRU de Lille); 🇫🇷 Lille, 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

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France

CHRU Hôpital Bretonneau; 🇫🇷 Tours, France

Hôpital Pierre Paul Riquet - Purpan (CHU); 🇫🇷 Toulouse, France