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Clinical Studies

Closed for Enrollment

  • Automated Liver and Spleen Volumes in CT (LSV-AI-V001) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate an artificial intelligence (AI) algorithm for generation of liver and spleen volumes from abdominal CT exams, performed with intravenous contrast unless contraindicated, as part of clinically indicated examinations. The clinical indications include chemotherapy, chronic liver disease, focal liver lesions and undergoing surgical liver resections or minimally invasive procedures involving the liver and spleen. AI algorithm will be used to measure liver and spleen volumes after the clinical CT exam is done to test whether reading radiologists will accept these AI-generated measures, populate them into their report. In addition, the study will assess feedback from reading radiologists. We will quantify their acceptance and/or rejection to determine if our software can be validated in a prospective study.

     
  • Comparative Non-Significant Risk MRI for Liver Fat Estimation (QIBA PDFF) Rochester, Minn.

    The purpose of this protocol is to further define two newly developed CSE-MRI methods (technical improvements of previously validated CSE-MRI methods) will be evaluated for conformance testing with the standard clinical method used at Mayo clinic (known as 3D-IDEAL-IQ) sequence.
  • Multi-Organ Magnetic Resonance Elastography to Monitor Treatment Response in Light Chain (AL) Amyloidosis Rochester, Minn.

    The purpose of this study is to perform multi-organ magnetic resonance elastography (MRE) in subjects with AL amyloidosis to determine feasibility of multi-organ MRE technique, and to perform multi-organ MRE in subjects with AL amyloidosis pre- and post-stem cell transplantation to obtain pilot data in patients who undergo stem cell transplantation for detection of changes post transplant.  
  • Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE); An FNIH Biomarkers Consortium Study (NIMBLE) Rochester, Minn.

    The purpose of this study is to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers.  The imaging biomarkers will cover an array of methods that could be applicable to non-alcoholic fatty liver disease (NAFLD), including liver fat, liver stiffness, corrected T1 relaxation time and body composition assessments. The data collected will be used to inform a decision of which of these biomarkers has sufficient precision to be advanced to NIMBLE Stage 2.

    NIMBLE is a comprehensive, five-year collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble).

     
  • Pilot and feasibility Study: Evaluation of New Quantitative MRI Parameters in Assessing the Kidneys of Autosomal Dominant Polycystic Kidney Disease (MRI Pilot) Rochester, Minn.

    The purpose of this study is to establish normal Magnetic Resonance quantitative values (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level Determination values for both renal cortex and medullary tissues and total renal blood flow) for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function, and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and normal renal function.

    Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness, Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization Transfer and renal blood flow) will have different values in young adult ADPKD patients as compared to normal volunteers.
  • Prospective study of gadolinium cholangiogram in the evaluation of biliary anatomy Rochester, Minn.

    The purpose of the study is to determine if gadolinium cholangiogram provides adequate biliary anatomy information required for surgical decision-making prior to living-related donor right lobe liver transplantation.
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