Geleen

Researchers are evaluating a new scan called FAPI-PET/CT to detect metastases in patients with advanced gastric cancer. The study aims to find out how well this scan identifies metastases and whether it reduces the burden on patients compared to current methods. Key questions include how often the scan changes treatment plans, such as avoiding unnecessary surgeries or switching to palliative care, and how it affects the diagnostic process with additional biopsies or surgery adjustments. Participants will receive the intravenous drug [18F]-FAPI-74 one hour before undergoing the FAPI-PET/CT scan. This scan is done after initial staging with gastroscopy and a contrast-enhanced CT but before a staging laparoscopy. Based on the scan results, the medical team will decide the next steps, which may include biopsy confirmation of suspect lesions or performing diagnostic laparoscopy if the scan is negative. During the study, participants will have one additional scan lasting about two hours (excluding travel) and complete several questionnaires totaling around four hours. Researchers will track changes in treatment intent for about one year and monitor changes in diagnostic work-up immediately after clinical staging involving FAPI-PET/CT and other diagnostic procedures. Safety and treatment decisions will be closely followed throughout the study period.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells used with Vivacit-E and Longevity highly crosslinked polyethylene (HXLPE) liners in patients undergoing primary or revision total hip arthroplasty. The study focuses on patients treated for various hip conditions such as degenerative joint disease, osteoarthritis, avascular necrosis, rheumatoid arthritis, fractures, and related disorders. The main goal is to confirm how well the implant system lasts and functions over a 10-year period. Participants will receive either the Vivacit-E or Longevity HXLPE liner, with 150 subjects assigned to each group. This dual cohort study involves implanting the G7 Acetabular System along with the assigned liner and instrumentation during hip replacement surgery. The study will monitor the implants and patients over time to assess device survival and clinical outcomes. During the study, participants will have follow-up visits where researchers will assess the survival of the implant using statistical methods and monitor any adverse events related to the implant or instrumentation. Patient-reported clinical outcome measures (PROMs) and radiographic results, if available, will be recorded to evaluate performance and benefits. Safety and effectiveness will be followed for up to 10 years after implantation.

Researchers are evaluating personalized blood thinner treatments after hip or knee replacement surgeries to reduce the risks of blood clots (venous thromboembolism or VTE) and bleeding. Currently, all patients receive the same standard blood thinner treatment, but some still develop blood clots while others experience bleeding. This study aims to see if adjusting the blood thinner dose and duration based on each patient's risk can lower these complications. Participants are divided into three groups based on their predicted risk of blood clots using a scoring system. Patients with low risk receive blood thinners only during their hospital stay. Those with intermediate risk are observed without changes to standard care. Patients with high risk get a higher dose and longer duration of blood thinners for six weeks. The blood thinners used include types such as LMWH or DOACs, given according to local guidelines and timing specified after surgery. Participants complete four questionnaires: one before surgery and three after surgery at 2 weeks, 6 weeks, and 3 months, to report any blood clots or bleeding events. If a participant experiences a clot, major bleed, or infection, an additional questionnaire about quality of life and joint function is sent one year later. No extra hospital visits are required. The main outcomes measured are blood clot and major bleeding events within 90 days after surgery.

Researchers are investigating treatment options for adults with newly diagnosed acute myeloid leukemia (AML) that have a mutation in the IDH1 gene and who are not eligible for intensive chemotherapy. The study aims to see if adding the drug venetoclax to the current standard treatment of ivosidenib and azacitidine improves outcomes and safety for these patients. The study is a phase 3 trial comparing the effects of venetoclax versus a placebo when combined with the standard treatment. Participants receive either venetoclax or placebo orally daily from day 1 through day 28 of each treatment cycle, alongside ivosidenib and azacitidine as part of their therapy. The study evaluates the treatment effects over multiple cycles, with details on dosing schedules maintained throughout. Those receiving placebo will follow the same schedule as those on venetoclax to ensure comparison accuracy. During the trial, participants are closely monitored through regular assessments including blood tests, genetic confirmation of IDH1 mutation, and safety evaluations. Researchers measure event-free survival twelve months after the last patient with AML is included to assess treatment effectiveness. Safety is also tracked throughout the study. The total participation duration depends on treatment cycles and follow-up requirements, with informed consent obtained before any procedures.

Multiple sclerosis (MS) is a common disease affecting the central nervous system and is a leading cause of neurological disability in young adults. This research aims to study the occurrence of spinal cord lesions in patients recently diagnosed with relapsing-remitting MS who are starting disease-modifying treatments (DMT). The study focuses on detecting asymptomatic spinal cord lesions using spinal cord MRI alongside routine brain MRI, and explores factors that may predict new lesions during early disease stages. Participants will undergo spinal cord MRI scans in addition to their regular brain MRIs over a 27-month follow-up period. Blood samples and clinical data will also be collected to analyze biomarkers like cerebrospinal fluid profiles, B-cell counts, and soluble blood markers. The study will evaluate how often spinal cord lesions appear without symptoms or brain MRI changes and investigate clinical features linked to these lesions. At the end of the follow-up, researchers will consider if an extension study is valuable. During the study, patients will have regular outpatient clinic visits and imaging assessments to monitor disease activity. The main outcome measured is the number of spinal cord lesions over 27 months. Blood and cerebrospinal fluid samples will be analyzed to identify markers associated with lesion development. Safety and ability to continue treatment will be monitored throughout the study period to better understand spinal cord involvement in MS progression.

Researchers are evaluating the use of commercially available targeted anticancer drugs for patients with advanced cancer who have specific molecular changes in their tumors. This phase 2, non-randomized study aims to describe how effective and safe these targeted treatments are for patients whose standard treatment options have been exhausted. It also seeks to improve patient access to these drugs by collaborating with pharmaceutical companies and performing next generation sequencing on fresh tumor biopsies to identify biomarkers. Participants receive targeted therapies matched to the molecular profile of their tumors, as determined by approved genomic or protein expression tests. The choice of drug is guided by a molecular tumor board, a knowledge library, and study coordinators. The protocol requires a fresh frozen tumor biopsy before treatment, with some exceptions for brain tumor patients or those with prior tissue testing. Various targeted drugs, including single agents and combinations, are administered according to molecular findings and drug-specific criteria. During the study, patients are monitored for tumor response, disease stability, and treatment-related serious side effects over six months following treatment start. Tumor assessments follow standard criteria, and treatment outcomes such as progression-free and overall survival are tracked. Safety and toxicity are carefully evaluated, and all patients receiving protocol drugs are followed to gather data on the benefits and risks of these personalized treatments.

Researchers are studying high-risk percutaneous coronary intervention (PCI) procedures used to treat blockages in the coronary arteries of patients with reduced heart function and complex artery narrowing. PCI usually involves inflating balloons and placing stents to open arteries but can cause temporary reductions in blood and oxygen flow, increasing the risk of complications like low blood pressure or cardiac arrest. This study examines whether adding mechanical circulatory support with the Pulsecath iVAC2L device during PCI improves patient outcomes compared to PCI without this device. The Pulsecath iVAC2L is a pulsatile mechanical pump placed in the left ventricle of the heart, which ejects blood into the aorta to support heart function during the procedure. This device aims to maintain natural blood flow patterns and protect the body's circulation better than existing continuous flow devices. The study compares PCI performed with the Pulsecath iVAC2L to PCI without mechanical support in patients undergoing high-risk procedures involving complex coronary lesions or impaired left ventricular function. Participants will be monitored for outcomes including death, cardiogenic shock, need for kidney replacement therapy or mechanical ventilation, and severe heart rhythm disturbances requiring resuscitation within 30 days after PCI. Throughout the study, researchers will assess safety and complications related to the device and procedure. The trial includes detailed assessments before, during, and after PCI to carefully evaluate the benefits and risks of using the Pulsecath iVAC2L in this patient group.