Imaging Core Lab Services

Source: ICON

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ICON Medical Imaging’s use of superior technology, advanced science and experienced people lead to the ultimate goal: results.

ICON Medical Imaging has acted as the imaging core lab for numerous studies recruiting 175,000+ subjects from more than 22,000 centers in 75 countries, successfully submitting over 150 imaging review charters to the US FDA. ICON Medical Imaging supports clients in the following areas:

  • Study Start-up
  • Project Management
  • Centralised Collection, Management, and Archival of Subject Image Data
  • Centralised Collection, Management and Archival of Selected Clinical Data received from our clients for integration with the imaging results
  • Centralised Expert Independent Blinded Image Review
  • Final Delivery of all Image Data, Clinical Data, and Study Documents at Trial Completion to our clients or their associates as required

Delivery begins with precise and thorough analysis of image data which provides our sponsors with:

  • Sophisticated 3D volumes
  • Measurements of metabolic changes
  • Measurements of physiological changes
  • Rigorous blinded read designs
  • Electronic case report forms collecting data with built-in logical checks
  • Access to worldwide blinded read facilities
  • Stringent quality checks throughout the process
  • Integrated image databases
  • Permanent archives to our clients or regulatory authorities

Therapeutic Experience

ICON Medical Imaging uses the most advanced validated quantitative imaging software to calculate imaging endpoints. The following list represents a sample of the therapeutic areas in which ICON Medical Imaging has conducted studies:

  • Oncology: Breast, Colorectal, Gastric, Glioblastoma, Glioma, Head and Neck, Lung, Lymphoma, Melanoma, Ovarian, Prostate, Renal Cell, Thyroidosis
  • Cardiovascular: Acute Myocardial Infarction, Carotid Vascular Disease, Cerebrovascular Disease, Congestive Heart Failure, Drug-induced cardiotoxicity, Great Vessel Aneurysm, Myocardial ischemia, Peripheral Vascular Disease
  • Neurology / CNS: Alzheimer ’s disease, Brain Tumors, Cerebrovascular Disease, Multiple Sclerosis, Parkinson’s Disease, Schizophrenia, Stroke
  • Diagnostic Agents: Radionuclide’s, Ultrasound Contrast Agents, X-ray Contrast Agents, MR Contrast Agents
  • Musculoskeletal: Rheumatoid Arthritis, Osteoarthritis, Psoriatic Arthritis
  • Medical Devices

Imaging Modalities

ICON Medical Imaging has the flexibility to deal with studies based on all major imaging formats including:

  •     Angiography
  •     Computed Tomography (CT)
  •     Echocardiography
  •     Magnetic Resonance Imaging (MRI)
  •     Nuclear Medicine
  •     Positron Emission Tomography (PET)
  •     Photography
  •     Ultrasound
  •     X-Ray

Imaging Biomarkers

The most significant recent advances are numerous and relate to molecular imaging advances. Among these are molecular probes such as FDG PET, dynamic contrast enhanced MRI and the use of tumour volumes for cancer trials rather than the sum of maximum diameter of the tumour lesions.

Imaging biomarkers also permit the actual visualisation of the Pharmacodynamic effects of drugs and responses to treatment, accelerating the drug development process while dramatically decreasing both time and cost.

Key Imaging Technology Platforms:  CT, MRI, SPECT, PET, Ultrasound, and X-Ray   

Imaging in Early Development

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. 

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

Regualtory Expertise

ICON Medical Imaging monitors and continually updates our processes with current industry practices and assessment criterias including:

  • RECIST 1.0 and RECIST 1.1
  • Cheson (1999 and 2007)
  • WHO
  • MacDonald
  • RANO
  • SWOG
  • Volumetric CT
  • PCWG2