Skip to main content
OpenTrials
Completed

NCT Number: NCT04265209

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Avicenne, Bobigny, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 35 to 80 (male or female)
  • Patients:
  • suffering from an essential tremor as defined by Elble's criteria from 2000 (excluding head tremor in decubitus and compatible with the study by the investigator)
  • or with Parkinson's disease as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB)
  • 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:
  • Patients with claustrophobia
  • Patients refusing to be informed in case of abnormalities detected during imaging tests
  • Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
  • Individuals with a known allergy to the active substance or one of the excipients of the product under investigation or to the reference product or to or to thyroid treatment
  • 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

Treatment and study plan

SPECT

Drug

[123I]-FP-CIT SPECT imaging procedure

PET

Drug

[18F] LBT-999 PET imaging procedure

Primary outcomes

  1. Sensitivity and specificity by visual analysis

    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.

    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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2020
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.