Imaging in Early Development

As the cost of drug development continues to rise and the number of drugs entering Phase I and II falls, drug development organisations are trending towards conducting fewer, more complex and intensely focused clinical trials. Consequently, innovative study design must maximise the results of early-phase trials to provide sponsors with necessary data to make informed go/no-go decisions and demonstrate proof-of-concept or proof-of mechanism.

Well-established medical imaging endpoints provide objective evidence of a drug’s safety and efficacy. To maximise the information found in these complex data sets; assessment guidelines, current technology tools, consistency in data collection, measurement techniques and expertise of the image reviewer, require thoughtful consideration.

ICON Medical Imaging’s Early Development Group

ICON Medical Imaging, offers specialised imaging services for early phase trials. Our Early Development Group provides a team of professionals whose focus is to help clients gather decision-grade data in a timely and cost-effective manner. ICON Medical Imaging’s early-development approach combines streamlined clinical operations and high-end scientific input with cost-conscious study design, helping clients make difficult decisions about their drug development strategies.  Our team includes radiologists, neuro-radiologists, statisticians, database programmers, medical writers, registered imaging technologists, radiation physicians and biomedical engineers who guide sponsors through the study process including support in definition of the appropriate imaging biomarker, site management, site training, quantitative data analysis and independent review services.

ICON Medical Imaging offers a complete service offering for early phase and exploratory Oncology, CNS and diagnostic studies including:

  • Analysis and consulting on translational data
  • Acquisition protocol design and support in study design
  • Site evaluation and management
  • Image management, quality control and preparation for analysis
  • Development of Imaging Charter or Methodology Manual
  • Dedicated reporting, including statistical analysis and complete data delivery and visualisation

Oncological services include:

  • PET assessments with FDG, FLT, FCH, FET, FDOPA and other standard oncological tracers based on various assessment algorithms including EORTC, total tumour burden measures and uptake pattern analysis
  • Radiologic assessments on CT/MRI including volumetric measures and density analysis (modified Choi) or RECIST and modifications thereof, Choi, MacDonald and RANO criteria as well as IWG Lymphoma assessments
  • Diffusion-weighted imaging (MRI) as well as perfusion measurements (MRI/CT)

CNS and diagnostics services include:

  • Support in all steps of PET tracer development phases
  • Alzheimer’s Disease support for FDG PET, Amyloid PET and volumetric MRI analysis
  • Parkinson’s and Huntington’s disease support for various PET and SPECT tracer analysis and MRI volumetric assessment
  • Multiple sclerosis support in MRI analysis of plaques

ICON will help you streamline your study design, provide efficient quality control of the image data and gather important information through biostatistical analysis. To learn more about how ICON Medical Imaging can offer you significant advantages in your early phase, methodological and proof-of concept studies, contact us today.