NCT04265209CompletedPhase 3
[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and 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.
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- First submitted
- 6 Feb 2020
- Start date
- 1 Dec 2021
- Primary completion date
- 2 Aug 2024
- Lead sponsor
- GE Healthcare
- Diseases
- Parkinson disease
- NCT number
- NCT04265209
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 152
- From 1 Dec 2021 to the primary completion date, 2 Aug 2024
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with deep brain stimulation
- 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
- Patients who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies
Other illness
- Patients with atypical non-idiopathic Parkinson's syndrome (multi system atrophy, progressive supranuclear palsy, etc.)
- Patients with severe and progressive psychiatric disorders
- Any other serious unstabilized chronic condition deemed incompatible with the study by the investigator
Age
- Woman of childbearing age without effective contraception in the opinion of the investigator
Other
- Patients with functional psychogenic movements
- Patients with disabling dyskinesia or essential tremor that are incompatible with imaging studies
- Patients unable to sign the informed consent
- Patients participating in a protocol or in a period of exclusion from a protocol
- 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
Who the study is looking for
- 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 with clinical symptoms dated more than 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
Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU) Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| CLCC Georges-François Leclerc C.G.F.L Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hôpital Roger Salengro (CHRU de Lille) Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU La Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Brabois / Hôpital Central (CHRU Nancy) Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Hôpital Laennec (CHU Nantes) Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Hospitalier Universitaire de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Chu La Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Eugène Marquis / CHU Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hôpital Pierre Paul Riquet - Purpan (CHU) Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHRU - Hôpital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.