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[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor

Primary Purpose

Parkinson Disease, Essential Tremor

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
SPECT
PET
Sponsored by
Zionexa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient:

    • suffering from an essential tremor according to the 2000 criteria of Elble (excluding head's tremor)
    • or with Parkinson's disease according to UKPDSBB criteria
  • Patient whose diagnosis is more than 18 months old
  • Patient affiliated with a health protection system or beneficiary of such a system
  • Patient who has received complete information on the organization of the research and signed his informed consent

Exclusion Criteria:

  • Patient with atypical non-idiopathic parkinsonian syndrome
  • Patient treated with deep brain stimulation
  • Patient suffering from abnormal functional psychogenic movements
  • Patient with severe and progressive psychiatric disorders
  • Patient with disabling dyskinesia or essential tremor, incompatible with performing imaging exams
  • Patient who had an ionizing examination at the cerebral level less than 3 months old
  • Person with a contraindication to performing PET or SPECT imaging:

    • Patient with claustrophobia
    • Patient refusing to be informed in case of abnormalities detected during imaging examinations
    • Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
    • Person with a known allergy to the active substance or to any of the excipients of the evaluated product or reference product or to potassium iodide
  • A woman of childbearing potential who does not have effective contraception according to investigator judgment
  • Patient unable to sign the informed consent
  • Patient participating to a protocol or period of exclusion from a protocol
  • Patient who received benefits over € 4,500 in the last 12 months prior to inclusion in clinical studies
  • Patient in exclusion period in national volunteer file during which he can not participate in another clinical study
  • Patient not affiliated to a health protection system
  • Patient refusing to participate
  • Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code:

    • Pregnant or lactating woman
    • Person deprived of liberty by a judicial or administrative decision,
    • Person under psychiatric care
    • Person admitted to a health or social institution for purposes other than research
    • Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice)
    • Major person unable to express consent and who is not subject to a legal protection measure

Sites / Locations

  • Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)Recruiting
  • Hôpital Henri Mondor
  • Hôpital Roger Salengro (CHRU de Lille)Recruiting
  • CHU La Timone
  • Hôpital Brabois / Hôpital Central (CHRU Nancy)Recruiting
  • Hôpital Laennec (CHU Nantes)
  • Centre Hospitalier Universitaire de NîmesRecruiting
  • CHU La Pitié SalpêtrièreRecruiting
  • Centre Eugène Marquis / CHU Pontchaillou
  • Hôpital Pierre Paul Riquet - Purpan (CHU)Recruiting
  • CHRU Hôpital BretonneauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

SPECT and PET

PET and SPECT

Arm Description

[123I]-FP-CIT SPECT imaging procedure first, then [18F] LBT-999 PET Imaging procedure

[18F] LBT-999 PET imaging procedure first, then [123I]-FP-CIT SPECT imaging procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2020
Last Updated
January 23, 2023
Sponsor
Zionexa
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1. Study Identification

Unique Protocol Identification Number
NCT04265209
Brief Title
[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zionexa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPECT and PET
Arm Type
Other
Arm Description
[123I]-FP-CIT SPECT imaging procedure first, then [18F] LBT-999 PET Imaging procedure
Arm Title
PET and SPECT
Arm Type
Other
Arm Description
[18F] LBT-999 PET imaging procedure first, then [123I]-FP-CIT SPECT imaging procedure
Intervention Type
Drug
Intervention Name(s)
SPECT
Intervention Description
[123I]-FP-CIT SPECT imaging procedure
Intervention Type
Drug
Intervention Name(s)
PET
Intervention Description
[18F] LBT-999 PET imaging procedure
Primary Outcome Measure Information:
Title
Sensitivity and specificity by visual analysis
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient: suffering from an essential tremor according to the 2000 criteria of Elble (excluding head's tremor) or with Parkinson's disease according to UKPDSBB criteria Patient whose diagnosis is more than 18 months old Patient affiliated with a health protection system or beneficiary of such a system Patient who has received complete information on the organization of the research and signed his informed consent Exclusion Criteria: Patient with atypical non-idiopathic parkinsonian syndrome Patient treated with deep brain stimulation Patient treated with invasive brain surgery (gamma knife, ultrasound, etc) Patient suffering with functional psychogenic movements Patient with severe and progressive psychiatric disorders Patient with disabling dyskinesia or essential tremor, incompatible with performing imaging exams Patient who had an ionizing examination at the cerebral level less than 3 months old Person with a contraindication to performing PET or SPECT imaging: Patient with claustrophobia Patient refusing to be informed in case of abnormalities detected during imaging examinations Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline Person with a known allergy to the active substance or to any of the excipients of the evaluated product or reference product or to potassium iodide A woman of childbearing potential who does not have effective contraception according to investigator judgment Patient unable to sign the informed consent Patient participating to a protocol or period of exclusion from a protocol Patient who received benefits over € 4,500 in the last 12 months prior to inclusion in clinical studies Patient in exclusion period in national volunteer file during which he can not participate in another clinical study Patient not affiliated to a health protection system Patient refusing to participate Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code: Pregnant or lactating woman Person deprived of liberty by a judicial or administrative decision, Person under psychiatric care Person admitted to a health or social institution for purposes other than research Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice) Major person unable to express consent and who is not subject to a legal protection measure
Facility Information:
Facility Name
Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clement Bouvet, Dr
Phone
+33(0) 4.73.27.80.81
Email
Clement.bouvet@clermont.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Ana Marques, Dr
Phone
+33 (0)4 73 75 47 90
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Roger Salengro (CHRU de Lille)
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Defebvre, Pr
Phone
+33 (0)3 20 44 67 30
Email
luc.defebvre@chu-lille.fr
First Name & Middle Initial & Last Name & Degree
Hélène Lahousse, Dr
Phone
+33 (0)3 20 44 59 62
Facility Name
CHU La Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Brabois / Hôpital Central (CHRU Nancy)
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Verger, Dr
Phone
+33 (0)3 83 15 39 11
Email
a.verger@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Lucie Hopes, D
Phone
+33 (0)3 83 85 23 77
Facility Name
Hôpital Laennec (CHU Nantes)
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Castelnovo, Dr
Phone
+33 (0)4 66 68 32 61
Email
giovanni.castelnovo@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Laurent Collombier, Dr
Phone
+33 (0)4 66 68 32 46
Facility Name
CHU La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Corvol, Pr
Phone
+33 (0)1 42 16 57 66
Email
jean-christophe.corvol@aphp.fr
First Name & Middle Initial & Last Name & Degree
Marie-Odile Habert, Dr
Phone
+33 (0)1 42 17 64 97
Facility Name
Centre Eugène Marquis / CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Pierre Paul Riquet - Purpan (CHU)
City
Toulouse
ZIP/Postal Code
3100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Rascol, Pr
Phone
+33 (0)5 61 77 91 03
Email
cic.1436@inserm.fr
First Name & Middle Initial & Last Name & Degree
Anne Hitzel, Dr
Phone
+33 (0)5 61 77 93 76
Facility Name
CHRU Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria-Joao Santiago-Ribeiro, Pr
Phone
+33 (0)2 47 47 97 28
Email
maria.ribeiro@univ-tours.fr
First Name & Middle Initial & Last Name & Degree
Jérémie Belin
Phone
+33 (0)2 47 47 37 23

12. IPD Sharing Statement

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[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor

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