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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zionexa

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