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NCT04265209CompletedPhase 3

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

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.

Source: ClinicalTrials.gov · Last updated 17 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
152 (actual)
First submitted
6 Feb 2020
Start date
1 Dec 2021
Primary completion date
2 Aug 2024
Lead sponsor
GE Healthcare
NCT number
NCT04265209

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 152
  • From 1 Dec 2021 to the primary completion date, 2 Aug 2024
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients treated with deep brain stimulation
  • 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
  • Patients who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies

Other illness

  • Patients with atypical non-idiopathic Parkinson's syndrome (multi system atrophy, progressive supranuclear palsy, etc.)
  • Patients with severe and progressive psychiatric disorders
  • Any other serious unstabilized chronic condition deemed incompatible with the study by the investigator

Age

  • Woman of childbearing age without effective contraception in the opinion of the investigator

Other

  • Patients with functional psychogenic movements
  • Patients with disabling dyskinesia or essential tremor that are incompatible with imaging studies
  • Patients unable to sign the informed consent
  • Patients participating in a protocol or in a period of exclusion from a protocol
  • 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

Who the study is looking for

  • 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

Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopital Avicenne
Coordinator of this site? Confirm its status
BobignyFranceUnknown status
CHU Bordeaux
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BordeauxFranceUnknown status
Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)
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Clermont-FerrandFranceUnknown status
Hopital Henri Mondor
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CréteilFranceUnknown status
CLCC Georges-François Leclerc C.G.F.L
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DijonFranceUnknown status
Hôpital Roger Salengro (CHRU de Lille)
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LilleFranceUnknown status
Hospices Civils de Lyon
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LyonFranceUnknown status
CHU La Timone
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MarseilleFranceUnknown status
Hôpital Brabois / Hôpital Central (CHRU Nancy)
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NancyFranceUnknown status
Hôpital Laennec (CHU Nantes)
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NantesFranceUnknown status
Centre Hospitalier Universitaire de Nîmes
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NîmesFranceUnknown status
Chu La Pitie Salpetriere
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ParisFranceUnknown status
Centre Eugène Marquis / CHU Pontchaillou
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RennesFranceUnknown status
Institut de Cancérologie Strasbourg Europe
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StrasbourgFranceUnknown status
Hôpital Pierre Paul Riquet - Purpan (CHU)
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ToulouseFranceUnknown status
CHRU - Hôpital Bretonneau
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ToursFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.