Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPECT and PET | Other | [123I]-FP-CIT SPECT imaging procedure first, then [18F] LBT-999 PET Imaging procedure |
|
| PET and SPECT | Other | [18F] LBT-999 PET imaging procedure first, then [123I]-FP-CIT SPECT imaging procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT | Drug | [123I]-FP-CIT SPECT imaging procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Patients aged 35 to 80 (male or female)
Patients:
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
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne | Bobigny | 93000 | France | |||
| CHU Bordeaux |
Not provided
Not provided
Not provided
Not provided
Not provided
| PET |
| Drug |
[18F] LBT-999 PET imaging procedure |
|
| Bordeaux |
| 33076 |
| France |
| Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU) | Clermont-Ferrand | 63000 | France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| CLCC Georges-François Leclerc C.G.F.L | Dijon | 21000 | France |
| Hôpital Roger Salengro (CHRU de Lille) | Lille | 59037 | France |
| Hospices Civils de Lyon | Lyon | 69500 | France |
| CHU La Timone | Marseille | 13005 | France |
| Hôpital Brabois / Hôpital Central (CHRU Nancy) | Nancy | France |
| Hôpital Laennec (CHU Nantes) | Nantes | 44093 | France |
| Centre Hospitalier Universitaire de Nîmes | Nîmes | 30029 | France |
| CHU La Pitié Salpêtrière | Paris | 75013 | France |
| Centre Eugène Marquis / CHU Pontchaillou | Rennes | 35000 | France |
| Institut de cancérologie Strasbourg Europe | Strasbourg | 67033 | France |
| Hôpital Pierre Paul Riquet - Purpan (CHU) | Toulouse | 3100 | France |
| CHRU Hôpital Bretonneau | Tours | 37044 | France |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided