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Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999 (LBT 999)

Primary Purpose

Idiopathic Parkinson Disease

Status
Terminated
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
[18F] LBT-999 PET
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Parkinson Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients

controls subjects

Arm Description

10 idopathic parkinson disease

10 healthy controls (no parkinson disease)

Outcomes

Primary Outcome Measures

Binding potential of [18F] LBT-999

Secondary Outcome Measures

DAT striatal density by estimating the LBT-999 distribution volume
presence of lipophilic metabolites

Full Information

First Posted
March 6, 2015
Last Updated
May 24, 2017
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02393027
Brief Title
Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999
Acronym
LBT 999
Official Title
Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Enough inclusions for interpretation
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
10 idopathic parkinson disease
Arm Title
controls subjects
Arm Type
Active Comparator
Arm Description
10 healthy controls (no parkinson disease)
Intervention Type
Drug
Intervention Name(s)
[18F] LBT-999 PET
Primary Outcome Measure Information:
Title
Binding potential of [18F] LBT-999
Time Frame
one year
Secondary Outcome Measure Information:
Title
DAT striatal density by estimating the LBT-999 distribution volume
Time Frame
one year
Title
presence of lipophilic metabolites
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts 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
Facility Information:
Facility Name
University Hospital
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999

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