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MEDIDATA has a long-standing track record in imaging techniques and methods approved as surrogate endpoints in later-phase clinical trials, as well as in exploratory imaging techniques for earlier clinical research settings.
We have experience in all common imaging modalities. Recent clinical trial examples include:
Computed Tomography (CT)
- Evaluation of solid-tumor response according to RECIST and evaluation of progression-free survival / time-to progression in a phase III colorectal cancer trial.
- Automatic versus manual segmentation of coronary segments in a phase IV study using CT angiography in coronary artery disease.
- Quantitative and qualitative evaluations of renal perfusion, permeability, and regional blood volume using PIViewer-generated, color-coded parameter maps in a phase II renal carcinoma study.
Positron Emission Tomography - Computed Tomography (PET-CT)
- Evaluation of metabolic tumor activity using standardized uptake values (SUVs) in a phase II colorectal cancer study.
Magnetic Resonance Imaging (MRI)
- Automated whole brain and manual hippocampus volumetry in a phase II Alzheimer's disease study.
- Qualitative assessments of rCBV, rCBF, TTP, %-signal-loss and MTT on PIViewer- generated color-coded parameter maps derived from perfusion weighted cerebral magnetic resonance images in phase II studies of acute ischemic stroke and of carotid artery stenosis.
- Evaluation of ventricular function (systolic/diastolic volumes, ejection fractions) in a phase IV study using cardiac MRI.
Sonography / Ultrasound
- Evaluation of ventricular function (systolic/diastolic volumes, ejection fractions) in a phase IV study on the use of 3D sonography after myocardial infarction.
- Characterization of focal liver lesions in a phase II trial of patients with suspected malignant liver disease.
Optical Coherance Tomography
- Evaluation of neurodegeneration (retinal nerve fiber layer thickness, macula thickness & macula volume) in a phase III multiple sclerosis trial.
Digital Subtraction Angiography (DSA)
- Evaluation of motion artifacts and pain in a phase IV pilot study on intravascular iodine-based contrast agents.
Single photon emission computed tomography (SPECT-CT)
- Tracing of a 177Lu labeled hormone in a phase I prostate cancer trial.
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