GE Health­care launches trial for PET imag­ing agent

BioSpectrum (India) - - SUPPLIER NEWS -

GE Health­care and Lan­theus Hold­ings, Inc., par­ent com­pany of Lan­theus Med­i­cal Imag­ing, Inc., have started a sec­ond Phase 3 clin­i­cal trial of Flurpiri­daz 18F (called the AURORA study), an in­ves­ti­ga­tional agent bein g eval­u­ated for the de­tec­tion of coro­nary artery disease (CAD), the most com­mon form of heart disease. The AURORA study is an in­ter­na­tional, mul­ti­cen­ter study to eval­u­ate di­ag­nos­tic ef­fi­cacy of Flurpiri­daz 18F In­jec­tion positron-emis­sion to­mog­ra­phy (PET) my­ocar­dial per­fu­sion imag­ing (MPI) in the de­tec­tion of CAD. In this prospec­tive, open-la­bel, study, pa­tients with sus­pected CAD, for whom an in­tra­coro­nary an­giog­ra­phy (ICA) has been in­di­cated, will un­dergo a sin­gle-pho­ton emis­sion com­puted to­mog­ra­phy (SPECT) MPI and Flurpiri­daz 18F In­jec­tion PET MPI prior to the per­for­mance of coro­nary an­giog­ra­phy. The pri­mary end­point is the di­ag­nos­tic ef­fi­cacy (sen­si­tiv­ity and speci­ficity) of Flurpiri­daz 18F In­jec­tion PET MPI for the de­tec­tion of sig­nif­i­cant CAD.

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