SPECT
Drug[123I]-FP-CIT SPECT imaging procedure
NCT Number: NCT04265209
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.
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Notify Me35 year–80 year
All sexes
Interventional
Phase 3
Hôpital Avicenne, Bobigny, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
[123I]-FP-CIT SPECT imaging procedure
[18F] LBT-999 PET imaging procedure
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.
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.
GE Healthcare
Industry
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.
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