Lausanne

Researchers are working to create a comprehensive reference database focused on intracranial aneurysms (IA). This project aims to gather detailed clinical history, imaging data, biological samples, and other related information to better understand risk markers for aneurysm formation and rupture, along with prognostic factors for different management strategies. The study also seeks to develop patient-specific management protocols and assess how the database and its tools can improve care, reduce costs, and support new discoveries and industrial developments. Participants include patients with newly diagnosed or known intracranial aneurysms, healthy volunteers, and family members of patients with a familial history of IA. Data collected includes demographic details, medical history, imaging scans such as MRI angiography and CT angiography, and various biological samples like blood, cerebrospinal fluid, saliva, and stool. Participants are asked to provide consent for data and sample use, including genetic analysis and potential future research applications. There are no limits on the number of participants for this database. During the study, participants will provide access to their health records, complete questionnaires, and undergo imaging and sample collection. Researchers will track clinical outcomes, imaging results, and quality of life measures over time. The primary outcome is disease model validation over 5 years. Consent includes provisions for confidentiality, withdrawal without impact on care, and possible re-contact for additional information or consent. The study ensures safety through ethical oversight and insurance coverage for any direct harm related to participation.

Researchers are evaluating the use of [68Ga]Ga-FAPI-46 PET/CT imaging for staging head and neck squamous cell carcinoma (HNSCC) before surgery. This study focuses on the role of cancer-associated fibroblasts (CAFs) in creating a tumor microenvironment that may promote metastasis by remodeling tissue, supporting blood vessel growth, and suppressing immune responses. By targeting the fibroblast activation protein (FAP) expressed on CAFs, the imaging aims to identify lymph nodes likely to develop metastases and improve pre-surgical cancer staging. Participants with confirmed HNSCC scheduled for tumor and lymph node removal surgery will receive an intravenous injection of [68Ga]Ga-FAPI-46 at a dose of 2 MBq/kg (total 80-200 MBq). About 60 minutes after injection, a low-dose, non-contrast PET/CT scan lasting approximately 20 minutes will be performed to visualize tumor and lymph node involvement. This imaging will be added to standard imaging procedures such as MRI, CT, and [18F]-FDG PET/CT used before surgery. During the study, researchers will compare the PET/CT imaging results, including tumor size, volume, number and location of lesions, and tumor stage, to the pathology of surgically removed lymph nodes. The goal is to assess how well [68Ga]Ga-FAPI-46 PET/CT detects early metastatic or premalignant changes in lymph nodes. Participant involvement includes the imaging procedure and standard clinical assessments, with a focus on enhancing cancer staging accuracy to guide treatment decisions.

This research focuses on acute myocardial inflammation, a complex condition that includes acute cellular cardiac allograft rejection, cardiac sarcoidosis, and myocarditis caused by immune checkpoint inhibitors. Diagnosing these conditions early and accurately remains challenging, so the study aims to assess the accuracy of [68Ga]Ga-PentixaFor PET/CT scans as a non-invasive method to detect inflammatory cells involved in these diseases. The study is a Phase 2 pilot investigation looking for correlations between this imaging technique and current diagnostic tools. Participants will receive an injection of up to 50 micrograms of PentixaFor labeled with 150 MBq of Gallium-68, administered as a bolus 60 minutes before the PET/CT scan. This imaging procedure aims to visualize inflammation by measuring lesion number, location, and standardized uptake value (SUV) over one year. The study evaluates the potential of this scan to identify inflammation in the heart across the different patient groups. During the study, participants will be monitored through clinical follow-ups at the cardiology department. The researchers will analyze imaging results obtained by [68Ga]Ga-PentixaFor PET/CT to assess the number and sites of lesions as well as uptake values. Safety and diagnostic accuracy will be tracked throughout the follow-up period. The total duration for outcome measurement is one year after imaging.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Low back pain is a leading cause of disability worldwide and a common reason for visits to primary care. This research evaluates the effectiveness of a new multilevel care approach designed to improve how general practitioners manage low back pain. The study involves over 100 general practitioners in French-speaking Switzerland and aims to improve patient outcomes, reduce unnecessary imaging, and assess cost-effectiveness through a cluster randomized controlled trial comparing the new intervention to usual care. The multilevel intervention includes training for general practitioners to improve their confidence and adherence to guidelines, regular email reminders, patient education to address unhelpful beliefs, and a clinical care pathway tailored to patient risk levels. This pathway involves education, self-management, individual physiotherapy sessions, and multidisciplinary group management when needed. Physiotherapists receive specialized training, and occupational therapists provide assessments and tailored education for patients requiring multidisciplinary care. The intervention group receives these supports, while the control group continues usual treatment without additional training or resources. Participants are monitored over 12 months with questionnaires at multiple time points and administrative data collection. Outcomes measured include patient-reported disability, imaging rates, quality-adjusted life years, pain intensity, work participation, and practitioner prescribing behaviors. The study also explores how well the intervention is accepted and adopted by healthcare providers and patients via interviews and focus groups. Data analysis will consider clustering and aim to detect meaningful improvements in disability and cost-effectiveness.

Cancer is one of the leading causes of illness and death worldwide. Researchers are exploring biology-based, personalized treatment strategies using new technologies like artificial intelligence (AI) and next-generation sequencing (NGS). These tools help understand cancer biology and treatment pathways better, aiming to find new targeted therapies. The study focuses on the complex interactions between cancer cells and their surrounding environment, including immune cells, which influence cancer progression and treatment resistance. Understanding these relationships can improve knowledge of how cancer responds or resists treatments like immunotherapy and targeted therapies. The MOSAIC study combines various advanced data methods to analyze cancer tumors in detail. It gathers multiple types of data, including clinical information, microscopic images, and spatial transcriptomics, from over 2,000 tumor samples across different cancers. Additional data types such as bulk RNA sequencing, whole exome sequencing, single-cell transcriptomics, and other molecular profiling may also be collected based on sample availability and technical feasibility. Patients enrolled have a confirmed cancer diagnosis with available preserved tumor tissue samples from previous biopsies or surgeries. Participants provide tumor samples and clinical data, which are integrated and analyzed to identify new drug targets, patient subgroups needing specific care, and mechanisms of treatment response or resistance. The study tracks genes and proteins relevant to drug targeting or biomarkers from diagnosis until death, loss to follow-up, withdrawal, or study end in December 2028, for up to 16 years. This long-term observation aims to create a large, detailed atlas of cancer biology and treatment impact to support future therapy development.