Clinical Research Directory

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)

The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.

CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)

This clinical investigation is intended to confirm the application of a new intended purpose and a new indication for an already certified medical device. Therefore, it is a pivotal clinical investigation with a confirmatory type of design.

Spectral CT Protocol Optimization for Atherosclerotic Plaque CharacterizatION

The SCORPION study (Spectral CT Protocol Optimization for Atherosclerotic Plaque Characterization) is a retrospective and prospective observational research project aimed at improving the diagnostic accuracy of dual-energy CT (DECT) and photon-counting CT (PCCT) in the characterization of atherosclerotic plaques in the coronary and carotid arteries. Given that cardiovascular diseases remain a leading cause of mortality despite advances in prevention and treatment, optimizing non-invasive imaging methods is crucial. CT Angiography (CTA) has become the gold standard for diagnosing coronary artery disease and carotid stenosis, but existing techniques require enhancement to improve plaque characterization, which is vital for risk stratification and patient management. While DECT has demonstrated potential in differentiating tissue types, its clinical adoption has been slow due to a lack of broad validation. This study seeks to establish a standardized imaging protocol that will provide more precise and reproducible plaque characterization. The primary objective of the study is to develop a standardized method for characterizing atherosclerotic plaques using DECT based on retrospective datasets from Synlab. The first secondary objective is to validate this workflow with photon-counting CT data from an independent cohort at Fondazione Monasterio/CNR, ensuring the reliability of the technique across different imaging modalities. The second secondary objective involves defining an optimized DECT protocol using the energy spectrum of PCCT, ultimately refining imaging parameters for improved plaque assessment. The study is structured into two phases. In the retrospective phase, data from fifty patients with critical stenosis (greater than 75% narrowing of the artery) who previously underwent DECT scans are analyzed. This step focuses on optimizing imaging parameters, segmentation techniques, and post-processing workflows. In the prospective phase, another cohort of fifty patients undergoes scanning with photon-counting CT to validate the workflow developed in the first phase. The results will inform the refinement of an optimized DECT protocol, translating the benefits of photon-counting technology into more widely available DECT scanners. Patients included in the study must be at least sixty years old and have undergone DECT for cardiovascular imaging of the coronary or carotid arteries. The imaging process involves a third-generation dual-energy CT scanner (Somatom Force, Siemens) with high-resolution imaging settings, dual-energy tube voltages of 150 and 90 kV, ECG-gated acquisition, and the use of iodine contrast. The collected data is processed using various reconstruction techniques to extract quantitative imaging biomarkers, including total plaque volume, non-calcified and calcified plaque volumes, remodeling index, and degree of luminal stenosis. The study employs PyRadiomics, an open-source platform for radiomic feature extraction, to standardize data analysis and improve reproducibility. The expected outcome of this research is an improved molecular characterization of atherosclerosis, leading to more accurate risk stratification and predictive models for cardiovascular events. By refining imaging techniques, the study aims to enhance diagnostic precision and minimize unnecessary hospitalizations, ultimately improving patient outcomes. Furthermore, establishing a standardized DECT protocol will allow for broader clinical adoption, making advanced plaque characterization more accessible in routine cardiovascular assessments.

BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS

The advent of immunotherapy (immune checkpoint inhibitors \[ICI\]) has been an extremely important advancement for cancer treatment in recent decades. The anti-cancer effects of these agents is profound and can lead to radiological \'disappearance\' of the primary cancer and metastatic deposits. ICI are now commonly used in the treatment of multiple cancers including melanoma, kidney cancer, liver cancer and lung cancer. ICI can be used on their own or in combination with other agents such as vascular endothelial growth factor inhibitors (VEGFi) which is first line treatment for many patients. However, it has become clear that these drugs have cardiovascular side effects including high blood pressure and a reduction in the heart muscle pumping function. It is also increasingly recognised that ICIs may have a toxic effect on blood vessels resulting in an increased risk of heart attack or stroke. These side effects can have a significant impact on patients\' health and can lead to withdrawal of important cancer treatment. The mechanisms by which these side effects occur are unclear and have not been well described to date. The aim of this study is to examine the effect of ICI and VEGFi, both alone and in combination, on blood vessels and to understand their effects on blood markers and heart function. This study is observational and will not require any modification of cancer therapy. This study will aim to recruit patients diagnosed with cancer who are already planned to receive ICI or VEGFi alone or in combination at the Beatson West of Scotland Oncology Centre. Patients will undergo a vascular PET-CT scan before and 6 months after starting treatment. In addition patients will undergo echocardiography and tests of the function of the small blood vessels in the fingertips with a special machine (EndoPat). Blood and urine samples will also be collected.