Leuven

Researchers are investigating the effectiveness and cost-effectiveness of Attachment Based Family Therapy (ABFT) compared to Treatment As Usual (TAU) for young adults aged 18 to 25 who experience frequent suicidal thoughts. This mental health issue is a serious concern worldwide, especially in Belgium and the Netherlands, where suicide is a leading cause of death among young adults. Current treatments have limited success, and this study aims to see if ABFT, which focuses on improving family relationships, can better reduce suicidal thoughts and behaviors and support young adults and their families. The study is a randomized controlled trial involving 138 participants from multiple sites including hospitals, mental health centers, and private practices in Belgium and the Netherlands. Participants are assigned to either ABFT plus TAU or TAU alone. ABFT is a manualized therapy that strengthens parent-child attachment to create a secure support base, delivered in weekly sessions over about 16 weeks. TAU consists of existing standard treatments such as antidepressants, cognitive behavioral therapy, or dialectical behavior therapy, with limited family therapy. Parents or caregivers may be involved in both treatments. Participants will be assessed at baseline, immediately after treatment, and at 3, 6, and 12 months follow-up to measure changes in suicidality using questionnaires and therapist reports. Researchers will also evaluate cost-effectiveness, family functioning, depressive symptoms, and treatment adherence. The study aims to improve clinical guidelines and policymaking to enhance care for suicidal young adults and their families over a one-year period.

Researchers are investigating ankle and hindfoot problems caused by changes in the biomechanics of this area. The study focuses on how surgical treatments aimed at improving these biomechanical conditions may relate to clinical improvements. A new 3D Multisegment Foot Model has been validated and is now available at the UZ Leuven gaitlab to study many biomechanical parameters within the foot and ankle region. The study uses this 3D model combined with plantar pressure measurements and gait analysis to evaluate patients undergoing ankle and hindfoot reconstruction surgery. This integrated approach allows assessment of detailed biomechanical changes before surgery and one year after surgery. The surgical procedures studied include treatments for conditions such as Pes Planus, Posterior Tibial Tendon Dysfunction, and various types of arthrodesis and prosthesis. Participants will have biomechanical and clinical evaluations using the advanced 3D model and plantar pressure measurement at the UZ Leuven Movement Analysis Laboratory. Researchers will measure gait parameters before surgery and one year post-operation to link biomechanical changes with clinical outcomes. The study aims to better understand the relationship between reconstructive surgery and foot and ankle function over a long-term follow-up.

Adolescent Idiopathic Scoliosis (AIS) is a spine growth defect occurring mainly in children aged 10 to 14 years, affecting about 3% of these children. It causes lateral curves and spinal twists that lead to posture problems, back pain, and visible asymmetry such as uneven shoulders. Early diagnosis and treatment are important to prevent curve progression and reduce health complications. Current surgical planning mainly relies on two-dimensional (2D) static X-rays, which have limitations in capturing the three-dimensional (3D) and dynamic nature of the spine deformity, potentially affecting surgical outcomes and revision rates. The study explores the use of advanced 3D dynamic and mechanical information to improve decision-making for AIS treatment. Treatments include vertebral body tethering (VBT), a minimally invasive growth-modulating device approved by the FDA in 2019, used for skeletally immature patients whose curves do not respond to bracing. For more severe curves (50 degrees or more) with limited growth left, spinal fusion surgery is recommended. This study aims to identify key 3D dynamic parameters to guide the selection of fusion levels and improve surgical planning beyond current 2D-based methods. Participants will be patients aged 10 to 35 scheduled for VBT or selective fusion surgery. Researchers will collect and analyze 3D dynamic spine data and mechanical behavior up to 2 years after surgery. The study will assess posture, spinal curvature, mechanical stiffness, and related outcomes to enable evidence-based treatment decisions. This could improve patient satisfaction, reduce complications, and lower treatment costs by enhancing surgical planning with 3D dynamic insights.

Researchers are studying children with spastic cerebral palsy (CP) to understand how their muscles develop and grow at a microscopic level over time. The study aims to evaluate the tiny muscle structures in young children with CP and see how these relate to larger muscle features, neuromuscular symptoms like spasticity, and treatments such as botulinum toxin (BTX) injections. The goal is to better define muscle changes in CP and improve treatment approaches by identifying specific muscle and patient characteristics. The study involves collecting muscle biopsy samples using a minimally invasive needle technique at different times before and after BTX treatment or during other procedures requiring general anesthesia. Muscle samples will be analyzed for fiber size, types, capillary and satellite cell density, and muscle stem cell function. Children will be grouped by age and treatment history, with some followed over 1 to 2 years to track muscle changes over time. Muscle imaging and neuromuscular assessments will also be performed to relate microscopic findings to muscle volume, length, and activation patterns. Participants will undergo muscle biopsies, ultrasound scans, gait analysis, and clinical assessments of muscle symptoms at multiple time points. The study measures detailed microscopic muscle properties and their changes over time, as well as overall muscle structure and function. Researchers will monitor participants for up to 1 to 2 years depending on their group, to understand how muscle properties evolve and respond to treatment, aiming to develop better personalized therapies for children with CP.

Researchers are evaluating the use of [18F]-MFBG PET scans to assess heart nerve function and compare its accuracy to [123I]-MIBG SPECT scans. The main goal is to see how well these methods can distinguish between Parkinson's disease (PD) and multiple system atrophy (MSA), and between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). This study is conducted at two centers and includes healthy volunteers and patients with confirmed diagnoses of PD, MSA-P, DLB, and AD. The study also investigates how well [18F]-MFBG PET detects changes in heart nerve uptake compared to healthy people and patients with other conditions, and whether it matches or exceeds the accuracy of the current standard imaging method. Participants will undergo several scans and tests, including dynamic cardiac [18F]-MFBG PET, [123I]-MIBG SPECT, and brain [18F]-PE2I PET scans. The [18F]-MFBG PET scan involves injecting a radioactive tracer and performing detailed imaging over periods of up to two hours, sometimes including whole-body scans. Healthy volunteers also participate in a dosimetry study to measure tracer distribution and safety. All scans use low-dose CT for imaging support, and blood samples are taken during the imaging sessions to monitor tracer levels. During the study, participants will have multiple hospital visits for screening, MRI brain scans, neurological assessments, and the PET and SPECT imaging procedures. Researchers will collect data on how well [18F]-MFBG PET matches or improves upon [123I]-MIBG SPECT for diagnosing these neurological disorders. They will also study the relationship between heart uptake changes and brain dopamine transporter changes, autonomic dysfunction, and regional heart differences. The total number of participants is 113, and the study will analyze diagnostic accuracy after completing scans for different patient groups over an estimated three-year period.

Researchers are studying the use of [18F]AlF-OC PET/MRI to understand inflammation in carotid artery plaques in patients who recently had a stroke or transient ischemic attack (TIA) related to carotid artery disease. This study focuses on whether tracer uptake in the affected and unaffected carotid arteries can predict future cerebrovascular events like recurrent TIA, amaurosis fugax, stroke, or other vascular complications. It is a Phase 2, single-center study conducted at University Hospitals Leuven in Belgium. Participants will receive a single intravenous injection of 4 MBq/kg [18F]AlF-OC, followed by PET/MRI scans to measure tracer uptake at specific time points optimized during an initial protocol phase. The study includes a screening and baseline assessment, the imaging visit, and follow-up telephone interviews at 90 days, 1 year, and 3 years after the initial stroke or TIA. Both the symptomatic (culprit) and asymptomatic (non-culprit) carotid arteries will be assessed for tracer uptake. Throughout the study, participants will undergo imaging to quantify the uptake of the tracer in the carotid arteries, which is the primary outcome measure. Secondary outcomes include evaluating whether baseline tracer uptake can predict the recurrence of vascular events such as TIA, stroke, myocardial infarction, or vascular death over the 3-year follow-up period. Safety and overall health outcomes will also be monitored via follow-up interviews.

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 rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.