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

Sponsor
Zionexa (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04265209
Collaborator
(none)
112
Enrollment
3
Locations
2
Arms
30
Anticipated Duration (Months)
37.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
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.
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: SPECT and PET

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

Drug: SPECT
[123I]-FP-CIT SPECT imaging procedure

Drug: PET
[18F] LBT-999 PET imaging procedure
Other: PET and SPECT

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

Drug: SPECT
[123I]-FP-CIT SPECT imaging procedure

Drug: PET
[18F] LBT-999 PET imaging procedure

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and specificity by visual analysis [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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU) Clermont-Ferrand France 63000
2 Centre Hospitalier Universitaire de Nîmes Nîmes France 30029
3 Hôpital Pierre Paul Riquet - Purpan (CHU) Toulouse France 3100

Sponsors and Collaborators

  • Zionexa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zionexa
ClinicalTrials.gov Identifier:
NCT04265209
Other Study ID Numbers:
  • ZX-2018-LBT999-DATTEP-3
First Posted:
Feb 11, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease
Tremor
Essential Tremor

Study Results

No Results Posted as of Aug 22, 2022