|Since Schering´s multiple sclerosis treatment Betaferon®, 1995 the first drug to be successfully registered, based only on image, rather than clinical data, the potential of Imaging Endpoints to predict clinical outcome has been recognized in the industry.
Academic research continuously develops new fascinating imaging methodologies, allowing to address non-invasively in vivo almost every biological phenomenon. Whether you are interested in CNS, oncological or cardiovascular drug development, imaging provides you with the required data.
Depending on the project type, radiopharmaceutical expertise, problems of multicentric functional imaging, advanced physics or all at once, are required to implement such a project practically.
Like other endpoints in clinical research, image parameters are associated with statistical variance, specific for each imaging methodology. Knowledge of these effects allows for appropriate statistical study design.
The comprehensive project design made by ABX-CRO covering scientific, technical and clinical aspects of imaging studies alike, avoids onerous interaction with multiple external service providers.
ABX-CRO is partner of the EANM* in the initiative of Multicentre Nuclear Medicine.
PET with radio-labelled analogues of drug candidates allows to study drug-host interactions at the macroscopic or molecular level (e.g. organ pharmacokinetics, metabolism, in vivo receptor binding).
Dopamine D2 receptor ligand candidate, showing striatal binding
Functional MRI (fMRI) permits to investigate CNS activation in health & disease state, with & without pharmacological intervention. Specific pathological activation patterns have been reported in the literature to correlate with subjective symptoms as diverse as pain, additction, or anxiety, as well as with established rating scale tools, traditionally used to investigate such symptoms. FMRI can be used to quantitatively test drug effects to normalize pathological activation patterns, typically in the setting of a pharmacodynamic phase I study.
Brain areas, activated during different types of experimental pain
Multicentre PET or PET/CT with established radiotracers, such as [18F]FDG or more specific proprietary tracers, is increasingly included in modern oncological late phase trials for early outcome prediction.
Metabolic treatment response seen on [18F]FDG PET, inconclusive result on structural CT