Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPECT · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| SPECT and PET | OTHER | \[123I\]-FP-CIT SPECT imaging procedure first, then \[18F\] LBT-999 PET Imaging procedure |
| PET and SPECT | OTHER | \[18F\] LBT-999 PET imaging procedure first, then \[123I\]-FP-CIT SPECT imaging procedure |
| Name | Type | Description |
|---|---|---|
| SPECT | DRUG | \[123I\]-FP-CIT SPECT imaging procedure |
| PET | DRUG | \[18F\] LBT-999 PET imaging procedure |
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 ...
SPECT is a small molecule imaging agent under development by GE HealthCare Technologies Inc. for use in Parkinson Disease. It is being studied to help distinguish between Parkinson's Disease and Essential Tremor. The drug is currently in Phase 3 clinical development and remains investigational, not yet approved.
SPECT is a small molecule imaging agent that targets the dopamine transporter in the brain. It is designed to be used with positron emission tomography (PET) imaging to help differentiate Parkinson's Disease from Essential Tremor. The drug is being developed by GE HealthCare Technologies Inc.
SPECT is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is conducting clinical trials to evaluate the drug for use in Parkinson Disease. SPECT is currently in Phase 3 development as an investigational imaging agent.
SPECT is currently in Phase 3 clinical development. It is an investigational small molecule imaging agent being studied for use in Parkinson Disease. The drug has completed one Phase 3 trial and is not yet approved by regulatory authorities.
SPECT has one completed Phase 3 clinical trial, NCT04265209, which enrolled 152 participants. The study compared [18F] LBT-999 PET to [123I]-FP/CIT SPECT to distinguish between Parkinson's Disease and Essential Tremor. The trial was conducted in France and included patients aged 35 years and older.