Leuven

Young adults aged 18 to 25 who experience frequent thoughts about killing themselves are the focus of this study, which evaluates the cost-effectiveness of Attachment Based Family Therapy ABFT compared to Treatment As Usual TAU. Suicide is a leading cause of death among young adults, and current treatments have limited success. This trial aims to determine if involving family through ABFT can better reduce suicidality and improve outcomes, informing clinical guidelines and care practices in Belgium and the Netherlands. Participants are randomly assigned to one of two groups the experimental group receives ABFT as an add-on to TAU, which includes treatments like antidepressants, CBT, or DBT, with weekly ABFT sessions lasting about 16 weeks. The control group receives TAU alone, allowing up to four sessions of systemic family therapy. ABFT focuses on strengthening parent-child attachment bonds to provide a supportive base for young adults, involving parents or caregivers actively in therapy. Throughout the study, suicidality is measured at baseline, immediately after intervention, and at follow-ups 3, 6, and 12 months post-intervention using tools like the Suicidal Ideation Questionnaire Junior. Researchers also assess depressive symptoms, family functioning, attachment, quality of life, and healthcare costs. The trial includes 138 participants across multiple sites, with double-blind randomized allocation. Safety, adherence, and cost-effectiveness are closely monitored during and after the treatment period.

Researchers are studying ankle and hindfoot conditions caused by biomechanical changes in this area. The trial focuses on how surgical treatments aimed at improving these biomechanical problems may relate to clinical improvements. A special 3D Multisegment Foot Model has been developed and validated to assess these biomechanical changes more precisely, and it is now used routinely at the gaitlab of UZ Leuven. The study evaluates patients who have undergone ankle or hindfoot reconstruction surgery. It uses advanced biomechanical assessments combining plantar pressure measurements and detailed 3D gait analysis with the Multisegment Foot Model. This integrated approach allows researchers to examine many biomechanical parameters within the foot and ankle region before surgery and one year after surgery. Participants will have assessments before their surgery and at multiple follow-up points including 6 months and 1 year after surgery. These assessments include gaitlab measurements, foot function questionnaires, health surveys, and pain scales. The study aims to link clinical outcomes with detailed biomechanical data, helping to better understand the effects of reconstructive surgery on foot and ankle function over time.

Adolescent Idiopathic Scoliosis AIS is a spinal growth defect mostly affecting prepubertal children aged 10 to 14 years, causing lateral curves and rotations of the spine. AIS can lead to posture problems, back pain, and visible asymmetry, such as uneven shoulders. Early diagnosis and proper treatment are important to stop curve progression and reduce related health issues. Current surgical decisions rely on two-dimensional X-rays, which may not capture the full three-dimensional and dynamic nature of the spines deformity, leading to suboptimal outcomes and revision surgeries. Treatment options include wearing a brace for immature patients with curves between 25 and 40 degrees. If the curve does not respond and growth potential remains, vertebral body tethering VBT, a minimally invasive FDA-approved device that gradually corrects scoliosis by slowing growth on one side, may be considered. For curves of 50 degrees or more with little growth left, spinal fusion surgery is recommended to permanently correct the spine by attaching vertebrae with surgical hardware. The study aims to improve surgical planning by using 3D dynamic and mechanical information from musculoskeletal models, moving beyond current 2D static assessments. Participants will undergo questionnaires, radiological EOS scans, and 3D dynamic motion analyses to gather detailed data on spinal deformity and mechanics. Researchers will measure 3D dynamic parameters up to two years after surgery and develop biomechanically-informed 3D models specific to AIS. This approach hopes to help surgeons make evidence-based decisions, improve patient outcomes, reduce complications, and lower the costs associated with AIS treatment. The study is sponsored by Universitaire Ziekenhuizen KU Leuven and involves patients aged 10 to 35 undergoing VBT or selective fusion surgery.

Researchers are investigating how muscle development and growth are altered at the microscopic level over time in children with cerebral palsy CP. This study focuses on understanding the microscopic muscle properties in young children with CP and how these relate to larger muscle features, neuromuscular symptoms, and treatments like botulinum toxin BTX injections. The goal is to identify different CP muscle types and improve personalized treatment strategies. The study collects muscle biopsies using a minimally invasive needle technique, sometimes under general anesthesia during routine treatments like BTX injections or orthopedic procedures. Biopsies will be taken from children with CP at varying ages and treatment stages and from typically developing children during surgeries. The research includes analyzing muscle fiber size, satellite cells, collagen content, and genetic factors. One part of the study follows changes before and after BTX treatment over up to 1.2 years. Participants will undergo ultrasound muscle imaging, clinical assessments of spasticity and strength, and gait analysis. Muscle biopsies are collected at multiple time points for detailed microscopic examination. Researchers will measure changes in muscle fiber characteristics, muscle volume and length, and muscle activation patterns. Data will be used to define integrated muscle and symptom profiles and how they respond to treatments over the study period, which may last up to 1.2 years for some participants.

Researchers are evaluating the use of 18F-MFBG PET scans to assess heart nerve activity in people with Parkinsons disease PD, multiple system atrophy MSA, dementia with Lewy bodies DLB, and Alzheimers disease AD. The study compares this method with the current standard 123I-MIBG SPECT scans, focusing on distinguishing between PD and MSA as well as DLB and AD. This is a prospective study conducted at two centers, aiming to validate the accuracy and feasibility of 18F-MFBG PET for these neurological conditions. Participants will undergo several imaging tests including dynamic cardiac 18F-MFBG PET, 123I-MIBG SPECT, and cerebral 18F-PE2I PET scans. Healthy volunteers and patients with confirmed diagnoses will be included, with groups divided by age and disease duration. A dosimetry study will also be conducted for healthy volunteers to measure radiation exposure from 18F-MFBG. Multiple visits to the hospital are required for scans and assessments. During the study, participants will have thorough neurological assessments, brain MRI scans, and blood sampling alongside PET and SPECT imaging. Researchers will evaluate diagnostic accuracy, effect size of tracer uptake changes, and relationships between heart nerve imaging and brain dopamine transporter changes and autonomic dysfunction. The study includes monitoring for safety and will analyze regional heart uptake patterns. Participants can expect 3 to 4 hospital visits with detailed imaging and clinical evaluations over the study period.

Researchers are evaluating the use of 18FAlF-NOTA-octreotide PETMRI to study inflammation in carotid artery plaques in patients who recently had a stroke or transient ischemic attack TIA in the carotid artery area. This study aims to see if the tracer uptake in affected and unaffected carotid arteries can predict future cerebrovascular events such as recurrent TIA, stroke, or other vascular problems. The trial is conducted as a Phase 2 study at University Hospitals Leuven and focuses on patients with at least 30% stenosis in the carotid artery. Participants receive a single intravenous injection of the radioactive tracer 18FAlF-OC, dosed at 4 MBqkg, followed by a saline flush. The study has two parts in the first, five patients undergo PETMRI scans at 60, 120, and 180 minutes after injection to refine the imaging protocol. In the second part, nineteen patients receive PETMRI at the optimal time point identified earlier. Both the symptomatic culprit and non-symptomatic carotid arteries are scanned. Participants will have a screening and baseline assessment, followed by the PETMRI imaging visit. They will be contacted by telephone for follow-up interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA. Researchers will measure the standardized uptake values SUV of the tracer in the carotid arteries as the primary outcome. Secondary outcomes include the prediction of recurrent cerebrovascular events, major cardiovascular events, and overall mortality during the three-year follow-up period.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers aim to improve understanding and treatment of brain metastases from solid tumors, which currently have limited systemic treatment options. This study focuses on patients with newly diagnosed non-CNS metastatic solid tumors who are at high risk of developing central nervous system CNS metastases. By gathering detailed clinical and biological information, including analyses of circulating tumor DNA ctDNA from cerebrospinal fluid CSF samples, the study seeks to identify new therapeutic targets and develop innovative treatment strategies. The study is organized into three time periods before the first CNS event Part A, at the first CNS diagnosis Part B, and after the first CNS event Part C. Participants will undergo scheduled collections of plasma, serum, CSF samples, and non-CNS metastatic tumor tissue as applicable, along with brain MRI scans at specific intervals depending on their part in the study. Sample collections and imaging are scheduled annually, every few months, or as clinically indicated, aligned with the participants cancer type and study period. Participants will have regular assessments including imaging and biological sample collections to monitor disease progression and tumor biology. Researchers will analyze the epidemiology and biology of CNS metastases over approximately eight years. Study procedures include lumbar punctures for CSF collection, brain MRIs, and collection of tumor tissue when possible. Participants safety and life expectancy are considered, and follow-up will continue throughout the study duration to support data collection and understanding of CNS metastases.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.