Sarcoidosis

Researchers are evaluating new imaging techniques in adults aged 18 to 85 with lung diseases such as asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM). The study aims to develop tools for analyzing lung function and structure using hyperpolarized Xenon 129 MRI alongside pulmonary function tests. This research is supported by Western University, Canada. Participants will undergo a series of tests during a one to two-hour visit, including medical history review, vital signs measurement, full pulmonary function testing following American Thoracic Society guidelines, proton MRI, specialized 129-Xe MRI scans using chest coils, and a low-dose thoracic CT scan. The MRI procedure includes monitoring heart rate and oxygen levels, providing hearing protection, and offering supplemental oxygen as needed. These imaging and testing methods help assess lung ventilation, diffusion, and gas exchange. During the study visit, participants will complete pulmonary function tests such as spirometry, plethysmography, and diffusing capacity tests. They will undergo magnetic resonance imaging with hyperpolarized Xenon gas to visualize lung airways and anatomy, along with CT scans matched to MRI breathing maneuvers. Researchers will measure ventilation defect percent (VDP), apparent diffusion coefficients (ADC), and dissolved phase spectroscopy over five years. Participant safety is monitored throughout the visit, and the total study duration includes these assessments and follow-up measures.

Researchers are investigating acute myocardial inflammation, a complex condition that includes acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS), and immune checkpoint inhibitor induced myocarditis (ICIM). This study aims to evaluate the accuracy of [68Ga]Ga-PentixaFor PET/CT imaging for detecting inflammatory cells in these patients, offering a potentially non-invasive diagnostic option. The study is a phase 2 trial focusing on these specific heart inflammation conditions where diagnosis is currently challenging. Participants will receive an intravenous injection of a maximum of 50 micrograms of PentixaFor labeled with 150 ±15 MBq of Gallium-68 ([68Ga]) as a bolus 60 ±15 minutes before undergoing PET/CT imaging. The treatment involves this imaging procedure for all three patient groups (ACR, CS, ICIM) to assess the presence and characteristics of myocardial inflammation. During the study, researchers will evaluate imaging results by analyzing lesion number, location, and standardized uptake value (SUV) over one year. They will also monitor toxicity data for safety assessment. Participants will have regular clinical follow-ups at the cardiology department. The study involves signing informed consent and includes monitoring for any adverse effects related to the imaging agent or procedures throughout the study duration.

Coughing is a common and distressing symptom for people with interstitial lung disease (ILD), affecting daily activities, work, and social life. This research explores a non-drug cough control therapy combined with pulmonary rehabilitation to see if it is practical and helps reduce chronic cough lasting more than eight weeks in ILD patients. The study aims to assess how well patients accept this therapy and whether it improves quality of life, cough symptoms, and fatigue compared to standard pulmonary rehabilitation alone. Participants will join a pulmonary rehabilitation program involving aerobic and strengthening exercises, disease-specific education, and self-management as usual care. Two weeks before finishing this program, they will receive four virtual sessions of 45 to 60 minutes each, focusing on cough control education and techniques. These sessions include assessing cough, learning suppression methods, breathing retraining, and reinforcing strategies to manage cough in daily life. During the study, researchers will track enrollment and attendance to measure feasibility, along with various clinical outcomes like cough severity questionnaires, fatigue scales, breathlessness ratings, and patient satisfaction interviews. The intervention is delivered online via Zoom, allowing remote participation. The total study duration averages one year, with ongoing assessments to understand the therapy's impact and participants' experiences.

Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy (SBRT) to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.

Researchers are conducting a Phase 1, open-label, randomized crossover study to evaluate how the study drug ibuzatrelvir is absorbed into the bloodstream of healthy adults. The trial compares the amount of ibuzatrelvir in blood after taking different tablet formulations, including the original and new tablets, both with and without food. The study also assesses the safety and tolerability of the medication. Participants will take a single dose of ibuzatrelvir in four different ways across four dosing periods: the original tablet fasted, the new tablet fasted, the new tablet dispersed in water fasted, and the new tablet fed. Each dosing period lasts 2 to 3 days, and participants will stay in the clinical research unit for 9 nights and 10 days to complete all dosing and procedures. The study uses a crossover design where each participant receives all treatment types in varied sequences. During the study, participants will have blood and urine samples collected for safety and to measure drug levels, with up to 40 blood draws for pharmacokinetics. They will also undergo up to 8 ECGs to monitor heart activity. Participants must fast overnight before most doses. After the inpatient stay, a follow-up phone call will occur 28 to 35 days after the last dose. Total participation lasts about 10 to 11 weeks.

Researchers are evaluating the safety and tolerability of inhaled mosliciguat combined with inhaled treprostinil in adults with pulmonary hypertension associated with interstitial lung disease (PH-ILD). This Phase 2, open-label, multi-center study focuses on participants who already use inhaled treprostinil to manage their condition. The trial aims to gather important safety information about this combination treatment in this specific lung disease population. Participants will receive daily inhaled mosliciguat during a 16-week open-label treatment period. After this period, those who complete the initial phase may continue to receive mosliciguat in an extension phase lasting beyond 16 weeks. Mosliciguat will be delivered using a dry powder inhaler device, and doses may vary among three different levels. All participants will continue treatment with inhaled mosliciguat during the extension. Throughout the study, researchers will monitor participants for treatment-emergent adverse events, serious adverse events, and any side effects leading to discontinuation, with assessments at baseline and at week 16. Participants must be able to perform a six-minute walk of at least 100 meters. The study includes imaging confirmation of interstitial lung disease and right heart catheterization to confirm pulmonary hypertension. The total participation duration may extend beyond 16 weeks depending on continuation in the extension phase.

Researchers are studying the natural progression of Interstitial Lung Disease (ILD) and related conditions such as Idiopathic Pulmonary Fibrosis, Sarcoidosis, and Connective Tissue Disorder. This observational study aims to collect data and blood samples from patients receiving care for ILD, as well as from a control group, to better understand the different expressions of these diseases. Participants include patients diagnosed with ILD and a control group without the disease. The study involves gathering data and blood samples during their care without any specific drug or treatment interventions. The observational nature means participants continue their usual medical care while contributing information to the research. During the study, researchers will monitor the natural history and course of ILD yearly through data collection and blood sampling. This includes tracking disease progression and characteristics over time. Participation involves regular assessments as part of routine clinical care, with no experimental treatments given. The study is sponsored by the University of Chicago and is ongoing through December 2030.

This research aims to assess the drug XTMAB-16 in adults with pulmonary sarcoidosis, a condition involving lung inflammation. The study is a combined Phase 1b/2 trial focusing on patients diagnosed at least six months prior, including those with or without additional organ involvement. It follows guidelines from leading respiratory societies and seeks to understand the drug's safety and effects while tapering corticosteroid use. Participants receive XTMAB-16 or a placebo through infusions at varying doses and schedules over two parts. In Part A, patients get doses every 2 or 4 weeks for 12 weeks, with four different dosing regimens including placebo. Part B continues treatment with the dose established in Part A for 24 weeks or placebo. Participants are asked to follow certain dietary restrictions and testing requirements during the study. Throughout the study, participants undergo monitoring for adverse events and steroid dose reductions, with evaluations lasting up to 34 weeks. Assessments include safety checks, lung function tests, and tracking corticosteroid use. The study measures include the rate of side effects, ability to reduce steroid doses, and maintenance of steroid reduction. Participants provide informed consent and receive ongoing support to comply with study procedures.

Researchers are conducting an observational prospective study to build a large-scale multiomic database of adult patients undergoing advanced imaging studies. The study focuses on using recently introduced photon counting CT scanners and high-field 3T MRI scanners to explore latent imaging information, called "opportunist features," which may provide new insights into disease risk and progression. This research aims to improve understanding of pathological mechanisms and enhance diagnostic and prognostic accuracy in fields such as oncology, neurology, pulmonary, and cardiovascular diseases. The study enrolls consecutive adults undergoing advanced imaging examinations at a single center using the Photon Counting CT scanner (Neaotom Alpha, Siemens) and 3T MRI (MR 7700, Philips). Imaging raw data along with conventional images will be stored. Clinical, demographic, and laboratory information, including genetic test results when available, will be collected at enrollment. Blood samples for lab analysis will be taken during contrast media administration when applicable. Annual updates through clinical visits, telehealth, or phone interviews will be conducted to gather follow-up clinical, lab, and imaging data over a 10-year period. Participants will be asked to provide informed consent and undergo routine imaging and clinical assessments as part of their standard care. Data collection includes questionnaires, interviews, and automatic record updates when examinations occur at the study site. Researchers will monitor the development of imaging signatures linked to disease prevention, diagnosis, and treatment. The primary outcome is the creation of a comprehensive multiomics archive to support broad scientific research, with yearly follow-ups for up to 10 years.

Researchers are conducting the American Lung Association (ALA) Lung Health Cohort, a multi-center, long-term observational study focusing on young adults aged 25 to 35 without severe lung disease. The study aims to understand lung health by examining various factors such as environmental exposures, physical activity, biomarkers, and respiratory cell activity to identify early markers and targets to prevent chronic lung diseases. Participants will undergo an initial baseline assessment to measure lung function, including pre-bronchodilator forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). After this, regular remote contacts through text, email, mail, or phone will be used to follow up with participants for up to 4.5 years. Pending additional funding, the study may be extended beyond 5 years to explore long-term changes in lung health. During the study, participants will provide contact information and undergo lung function tests. Follow-up data will be collected remotely to monitor lung health over time. Researchers will track lung function measures and gather information on environmental and lifestyle factors. Safety and participant status will be monitored regularly, with the total study duration potentially extending beyond 5 years depending on funding.