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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
152
Hôpital Avicenne
Bobigny, France
CHU Bordeaux
Bordeaux, France
Centre Jean PERRIN / Hôpital Gabriel Montpied (CHU)
Clermont-Ferrand, France
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.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Henri Mondor
Créteil, France
CLCC Georges-François Leclerc C.G.F.L
Dijon, France
Hôpital Roger Salengro (CHRU de Lille)
Lille, France
Hospices Civils de Lyon
Lyon, France
CHU La Timone
Marseille, France
Hôpital Brabois / Hôpital Central (CHRU Nancy)
Nancy, France
Hôpital Laennec (CHU Nantes)
Nantes, France
...and 6 more locations