Vasculitis

Researchers are investigating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a condition where lung and kidney involvement often leads to worse outcomes. This study aims to evaluate a new PET imaging tracer, 68Ga-Fibroblast Activation Protein Inhibitor (FAPI), which targets activated fibroblasts to detect disease activity and lesion distribution in AAV patients. Early and accurate diagnosis using this novel tracer could help personalize treatment and better assess disease severity and prognosis. The study will observe patients with AAV, including those with or without interstitial lung disease and renal dysfunction, using the 68Ga-FAPI PET/CT scan. This noninvasive imaging technique allows whole-body disease localization in a single exam. The study will compare disease severity and activity as measured by the PET/CT scan within four weeks after enrollment. No experimental treatments are administered since this is an observational study. Participants will undergo clinical evaluations and the PET/CT imaging to assess disease activity and severity. Researchers will collect clinical information and imaging data to provide insights on lesion distribution and organ involvement. The study requires informed consent and cooperation throughout the process. Total participation time varies, with the primary outcome measured within four weeks post-enrollment. Safety and compliance will be monitored during the study period, which runs until July 2028.

Researchers are studying pulmonary arterial hypertension (PAH), including its common subtypes idiopathic PAH (IPAH) and connective tissue disease-associated PAH (PAH-CTD). The study aims to develop pulmonary vascular biomarker signatures using hyperpolarized 129Xe MRI to differentiate these subtypes and to evaluate the ability of this imaging to monitor disease progression and treatment response over time. Additional assessments such as laboratory tests, echocardiography, and six-minute walk distance (6MWD) are also used to support these evaluations. The study is observational and enrolls 20 subjects divided into two groups: 10 with IPAH and 10 with PAH-CTD. Participants will undergo hyperpolarized 129Xe MRI and MR spectroscopy at baseline, 3 months, 6 months, and 12 months. Alongside imaging, data from standard clinical assessments including labs, echocardiography, and 6MWD will be collected at these same timepoints to track changes. Participants will be monitored for changes in pulmonary vascular remodeling, red blood cell oscillation amplitude, 6MWD, NTproBNP levels, and WHO functional class over one year. Safety is assessed by tracking adverse events, serious adverse events, withdrawals, and specific examinations such as electrocardiograms and vital signs. The total follow-up period for each participant is one year, with multiple scheduled evaluations to comprehensively assess disease status and response.

Researchers are studying the use of the imaging agent 68Ga Ga-FAPI in PET/CT scans to explore its potential in diagnosing and monitoring various chronic inflammatory and fibrotic diseases. This pilot study involves 13 different clinical conditions such as rheumatoid arthritis, liver fibrosis, systemic lupus, and others. The goal is to determine if this new imaging method can improve disease evaluation and support further clinical development in these areas. The study adds a 68Ga Ga-FAPI PET/CT scan to usual routine care. Depending on the condition and treatment plan, patients may have this scan once at the start or multiple times over 3 to 6 months if their therapy is intensified. This imaging agent targets the fibroblast activation protein (FAP), which is involved in tissue remodeling and fibrosis, helping to highlight disease activity in affected tissues. Participants will undergo the PET/CT scans along with routine clinical evaluations and may be followed up at baseline, 3 months, and 6 months. Researchers will measure PET uptake intensity and correlate imaging results with pathology findings, biomarkers, functional parameters, and imaging characteristics over time. The study aims to assess the usefulness of 68Ga Ga-FAPI PET/CT in improving diagnosis and monitoring of these chronic diseases while participants continue their usual care.

Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis (RA). This study focuses on understanding two main factors influencing pain relief: brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinib's impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors (TCRs) to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohn's disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are evaluating the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed or refractory B-cell related autoimmune diseases. This early phase 1 pilot study plans to enroll 15 patients to assess the treatment's safety, feasibility, and effectiveness. The study also explores how well KN5501 expands, persists, and depletes CD19 positive B cells in these patients. Participants will receive a preparatory treatment with Fludarabine and Cyclophosphamide on three days before the infusion of anti-CD19 CAR NK cells. The trial includes two dose levels (6x10^9 and 9x10^9 cells) for dose escalation. This is a single-arm, open-label study without a placebo group. During the study, researchers will monitor participants closely for dose limiting toxicities and adverse events within the first 4 weeks and at 12, 24, 36, and 52 weeks after infusion. Effectiveness will be evaluated by disease control and remission rates at the same time points. Participants will undergo regular assessments including clinical evaluations and laboratory tests, with follow-up lasting up to one year after treatment.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

This clinical trial focuses on giant cell arteritis (GCA), a common systemic vasculitis affecting older adults. The study evaluates a new imaging tracer called AzaFol using PET/CT scans to diagnose GCA. Researchers aim to compare AzaFol with the standard 2-[18F]FDG-PET/CT imaging to determine if AzaFol better distinguishes inflammation caused by vasculitis from atherosclerosis. The trial also assesses the safety and tolerability of AzaFol in people suspected of having GCA. Participants will receive both AzaFol-PET/CT and FDG-PET/CT imaging in a randomized order. One group undergoes AzaFol imaging first followed by FDG, while the other group has FDG first then AzaFol. The study is open-label and randomized, with imaging performed at a single timepoint per participant to compare the two tracers directly. During the study, participants will be evaluated mainly by the imaging results to measure the specificity and sensitivity of GCA diagnosis using AzaFol compared to FDG. Researchers will also analyze lesion detection rates visually and semi-quantitatively. Safety and tolerability of AzaFol will be monitored, and participants must comply with protocol requirements, including fasting and remaining still during scans. The study participation duration for each person is centered around these imaging procedures and assessments.

Researchers are establishing a prospective group of patients with plasma cell disorders (PCDs) to better understand these conditions and their treatments. This study focuses on various PCDs including multiple myeloma, amyloidosis, and other related disorders. It aims to explore how minimal residual disease (MRD) status relates to patient prognosis and investigate the role of the tumor microenvironment (TME) in the disease's development and progression. Patients with confirmed PCDs who are hospitalized and willing to participate will be followed over time. Biological samples such as peripheral blood, bone marrow aspirate, and urine will be collected before and after treatment to support future research. The study does not involve any intervention and participants will be regularly assessed at baseline, then at 1, 3, 6, and 12 months after treatment, followed by yearly visits. During the study, clinical and laboratory data along with biological samples will be gathered to analyze disease features and treatment responses. Follow-up visits will monitor patient progress and outcomes for up to ten years. The main outcome is to maintain a comprehensive cohort and understand the relationship between MRD and prognosis in PCD patients, while also supporting further studies on tumor clone evolution and disease mechanisms.

Researchers are studying the use of unlicensed cryopreserved cord blood units (CBUs) for transplantation in both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood-forming system. This observational study aims to evaluate outcomes such as the recovery of a certain level of white blood cells after transplantation, as well as the incidence of infections, infusion reactions, survival rates, and graft-versus-host disease over time. The study involves patients receiving unlicensed CBUs at multiple U.S. transplant centers. These CBUs are used for patients with hematologic malignancies and other blood disorders. The protocol collects data on patients who receive these unlicensed transplant units, without administering a new treatment but observing the outcomes after transplantation. Participants will be monitored for neutrophil recovery at 60 and 100 days post-transplant, along with assessments of infection transmission, infusion reactions, survival one year after transplant, and occurrences of acute and chronic graft-versus-host disease. Platelet engraftment levels will also be tracked. The study includes patients of any age and follows them through the transplantation and recovery process to gather information on these key outcomes.