Comparing two imaging techniques to differentiate Parkinson's Disease from Essential Tremor
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.
This study is testing a new PET imaging agent to see if it can better tell the difference between Parkinson's Disease and Essential Tremor in patients aged 35 to 80.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Zionexa Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 16 sites (Bobigny and 15 other locations) |
| Trial ID | NCT04265209 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a new PET imaging agent, [18F] LBT-999, in distinguishing between Parkinson's Disease and Essential Tremor compared to the established SPECT imaging method, [123I]-FP-CIT. The study will involve patients aged 35 to 80 who have been diagnosed with either condition for over 18 months. Participants will undergo imaging with both techniques to assess the performance of the new PET agent. The goal is to demonstrate that [18F] LBT-999 is at least as effective as the SPECT method in making accurate diagnoses.
Who should consider this trial
Good fit: Ideal candidates are patients aged 35 to 80 diagnosed with either Essential Tremor or Parkinson's Disease for more than 18 months.
Not a fit: Patients with atypical Parkinson's syndromes or those treated with deep brain stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses for patients with Parkinson's Disease and Essential Tremor, allowing for better-targeted treatments.
How similar studies have performed: Other studies have shown success in using advanced imaging techniques for differential diagnosis in movement disorders, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bobigny and 15 other locations
- Hôpital Avicenne — Bobigny, France (Not_yet_recruiting)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU) — Clermont-Ferrand, France (Recruiting)
- Hôpital Henri Mondor — Créteil, France (Recruiting)
- CLCC Georges-François Leclerc C.G.F.L — Dijon, France (Recruiting)
- Hôpital Roger Salengro (CHRU de Lille) — Lille, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- CHU La Timone — Marseille, France (Recruiting)
- Hôpital Brabois / Hôpital Central (CHRU Nancy) — Nancy, France (Recruiting)
- Hôpital Laennec (CHU Nantes) — Nantes, France (Recruiting)
- Centre Hospitalier Universitaire de Nîmes — Nîmes, France (Recruiting)
- CHU La Pitié Salpêtrière — Paris, France (Recruiting)
- Centre Eugène Marquis / CHU Pontchaillou — Rennes, France (Recruiting)
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (Not_yet_recruiting)
- Hôpital Pierre Paul Riquet - Purpan (CHU) — Toulouse, France (Recruiting)
- CHRU Hôpital Bretonneau — Tours, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.