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Parkinson DiseasePhase 3NCT04265209

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

A Phase 3 study testing SPECT and PET in people with Parkinson Disease and Essential Tremor, run by GE Healthcare at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Parkinson Disease, Essential Tremor
What is being tested?
SPECT and PET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
16 sitesFrance
Study dates
1 Dec 2021to 2 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • Hôpital Avicenne

    Bobigny, 93000

  • CHU Bordeaux

    Bordeaux, 33076

  • Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

    Clermont-Ferrand, 63000

  • Hôpital Henri Mondor

    Créteil, 94010

  • CLCC Georges-François Leclerc C.G.F.L

    Dijon, 21000

  • Hôpital Roger Salengro (CHRU de Lille)

    Lille, 59037

  • Hospices Civils de Lyon

    Lyon, 69500

  • CHU La Timone

    Marseille, 13005

  • Hôpital Brabois / Hôpital Central (CHRU Nancy)

    Nancy

  • Hôpital Laennec (CHU Nantes)

    Nantes, 44093

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029

  • CHU La Pitié Salpêtrière

    Paris, 75013

  • Centre Eugène Marquis / CHU Pontchaillou

    Rennes, 35000

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033

  • Hôpital Pierre Paul Riquet - Purpan (CHU)

    Toulouse, 3100

  • CHRU Hôpital Bretonneau

    Tours, 37044

Other trials in France

About this study

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.

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.

Being tested
SPECT, PET
Medical subject headings
Parkinson Disease, Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPECTDrug

    [123I]-FP-CIT SPECT imaging procedure

  • PETDrug

    [18F] LBT-999 PET imaging procedure

Study groups in NCT04265209
Study groupRoleWhat they receive
SPECT and PETOther[123I]-FP-CIT SPECT imaging procedure first, then [18F] LBT-999 PET Imaging procedure
Receives: Drug: SPECT; Drug: PET
PET and SPECTOther[18F] LBT-999 PET imaging procedure first, then [123I]-FP-CIT SPECT imaging procedure
Receives: Drug: SPECT; Drug: PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start1 Dec 2021
  3. Primary completion2 Aug 2024
  4. Study completion2 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04265209
Sponsor's protocol ID
ZX-2018-LBT999-DATTEP-3
Status last verified
Nov 2025
First submitted
6 Feb 2020
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPECT and PET in people with Parkinson Disease and Essential Tremor, run by GE Healthcare at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04265209.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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