Clinical trial NCT02393027: Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999
Official title: Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Idiopathic Parkinson Disease
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Idiopathic Parkinson's disease (IPD) is a degenerative disease affecting the dopaminergic system. Clinical symptoms of IPD commonly begin after the loss of at least 40 to 50% of striatal dopaminergic terminals (specially putaminal terminals).

The Dopamine neuronal transporter (DAT) is a highly expressed protein in the membrane of presynaptic nigrostriatal dopaminergic terminals. The use of a DAT's radioligand in the initial stages of the disease would lead to an early detection of nigral cell loss.

Currently, only one DAT's radioligand has obtained marketing authorization in France, the 123I-FPCIT, for use in Single Photon Emission Computed Tomography (SPECT).

Otherwise, the Positron Emission Tomography (PET), a more sensitive technology than SPECT with higher resolution has become for a few years the new gold standard for visual analysis and quantification of neurotransmission systems (including the dopaminergic system).

A DAT tracer labelled with Carbon 11 (\[11C\] PE2l) have been developed and is currently used as a reference in various research centers.

However, in order to enable a clinical use of this tracer (which currently can't be because of the too short period of Carbon 11), the unit INSERM U930 "Imaging and Brain" in collaboration with the CERRP (Center for Studies and Research on Radiopharmaceuticals) developed a new version of this tracer, labelled with 18-fluor: the \[18F\] LBT-999.

The main goal of this study is to compare the \[18F\] LBT-999 uptake between a group of patients suffering from a Parkinsonien syndrome to a group healthy volunteers.


Eligibility criteria: Inclusion Criteria:

Criteria common to all participants:

* Age between 45 and 75 years old
* Signed informed consent
* Affiliated to a social security system

Criteria for patients:

* idiopathic Parkinson's disease according to the UKPDSBB criteria
* stage 1-3 Hoen and Yahr (unilateral disease to moderate or mild bilateral disease in a self patient )

Criteria for healthy volunteers:

* matching according to age (± 5 years)

Exclusion Criteria:

Criteria common to all participants:

* history of taking an antipsychotic or any other drug with a dopaminergic effect in the previous 6 months
* contraindications to MRI
* person with severe claustrophobia
* patient with a legal protection measure
* alcohol or drug abuse history (in the past 10 years)
* history of progressive disease that can affect the central nervous system (blood pressure greater than or equal to 180/100 mmHg, chronic lung disease with hypoxia, heart failure stage 4)
* all medical and surgical affection older than 3 months
* history of stroke
* history of head trauma (coma\> 24h)
* MMS\<24
* pregnancy or lactating woman without reliable contraception

Primary outcomes:
measure: Binding potential of [18F] LBT-999
timeFrame: one year
Secondary outcomes:
measure: DAT striatal density by estimating the LBT-999 distribution volume
timeFrame: one year
measure: presence of lipophilic metabolites
timeFrame: one year
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital
Study officials:
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