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New brain scan could end misdiagnosis of Parkinson's and tremor

NCT ID NCT04265209

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new PET scan tracer, [18F] LBT-999, to see if it can distinguish Parkinson's disease from essential tremor as well as the current standard SPECT scan. Researchers compared the two imaging methods in 152 patients. If the PET scan works equally well, it could offer a more precise and potentially faster diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
[18F] LBT-999 (a radioactive tracer for PET imaging)
What this could lead to
If successful, this could provide a more accurate and accessible way to diagnose Parkinson's disease versus essential tremor, helping patients get the right treatment sooner.
What could go wrong
This is a completed Phase 3 study, but the new PET tracer may not prove as effective as the standard SPECT method. Also, PET scanners are less widely available than SPECT, limiting real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

152 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHRU Hôpital Bretonneau

    Tours, 37044, France

  • CHU Bordeaux

    Bordeaux, 33076, France

  • CHU La Pitié Salpêtrière

    Paris, 75013, France

  • CHU La Timone

    Marseille, 13005, France

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

    Dijon, 21000, France

  • Centre Eugène Marquis / CHU Pontchaillou

    Rennes, 35000, France

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029, France

  • Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)

    Clermont-Ferrand, 63000, France

  • Hospices Civils de Lyon

    Lyon, 69500, France

  • Hôpital Avicenne

    Bobigny, 93000, France

  • Hôpital Brabois / Hôpital Central (CHRU Nancy)

    Nancy, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Hôpital Laennec (CHU Nantes)

    Nantes, 44093, France

  • Hôpital Pierre Paul Riquet - Purpan (CHU)

    Toulouse, 3100, France

  • Hôpital Roger Salengro (CHRU de Lille)

    Lille, 59037, France

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033, France

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