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SPECT

Phase 3

Parkinson Disease | Small molecule | Neurology |GE HealthCare Technologies Inc.|Trials Updated: Nov 17, 2025

SPECT development status

Highest phase Phase 3
Registered trials 2 across 2 sponsors since Feb 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

SPECT clinical trials

SPECT · 1 trial · 2 indications

Phase 3 1
NCT04265209[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential TremorParkinson Disease
COMPLETED152 Analytics
PHASE3COMPLETED
[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
SPECT and PETOTHER\[123I\]-FP-CIT SPECT imaging procedure first, then \[18F\] LBT-999 PET Imaging procedure
PET and SPECTOTHER\[18F\] LBT-999 PET imaging procedure first, then \[123I\]-FP-CIT SPECT imaging procedure

Interventions

NameTypeDescription
SPECTDRUG\[123I\]-FP-CIT SPECT imaging procedure
PETDRUG\[18F\] LBT-999 PET imaging procedure
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Eligibility Criteria

Age Range35 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites16

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 ...

Countries:France
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Frequently asked questions about SPECT

What is SPECT used for in Parkinson disease?

SPECT is a diagnostic imaging agent being developed by GE HealthCare Technologies Inc. for Parkinson disease. It is studied as a [123I]-FP/CIT SPECT imaging approach to help distinguish between Parkinson's disease and essential tremor. It is a small molecule imaging agent, not a therapeutic treatment.

Who makes SPECT?

SPECT is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is the sponsor of the clinical program evaluating this imaging agent for Parkinson disease and essential tremor.

What phase is SPECT in?

SPECT is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program has enrolled 152 participants in total. SPECT is investigational and is not approved for commercial use.

What clinical trials is SPECT in?

SPECT has been evaluated in the Phase 3 trial NCT04265209, titled [18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor. The trial enrolled 152 participants, was controlled and randomized, and was conducted in France. It is now completed.

Is SPECT FDA approved?

SPECT is investigational and remains in clinical development. It has completed a Phase 3 trial but is not approved for commercial use. No approval status has been established for this imaging agent.