Geleen

Researchers are studying a new type of scan called FAPI-PETCT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PETCT scan, where a small amount of 18F-FAPI-74 is given intravenously about 60 minutes before a PETCT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations teclistamab with daratumumab and lenalidomide Tec-DR, and talquetamab with daratumumab and lenalidomide Tal-DR, against the standard treatment of daratumumab, lenalidomide, and dexamethasone DRd. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating whether customizing blood thinner treatment after hip or knee replacement surgery can reduce both blood clots and bleeding compared to the standard approach used for all patients. This study focuses on patients undergoing elective total hip or knee arthroplasty and aims to determine if shorter treatment is safe for low-risk patients and if higher doses for high-risk patients lower clot risks without causing too much bleeding. Participants are grouped based on their predicted risk of venous thromboembolism VTE using a risk score called TRiPplasty. Low-risk patients are randomly assigned to either a shortened prophylaxis during hospital stay only or standard treatment for about 4 weeks. High-risk patients are randomly assigned to receive intensified and extended prophylaxis for 6 weeks or standard treatment. Intermediate-risk patients participate in an observational arm without treatment changes. Treatments include types of blood thinners such as low molecular weight heparin or direct oral anticoagulants given according to Dutch guidelines. During the study, participants complete four questionnaires one before surgery, and at 2 weeks, 6 weeks, and 3 months after surgery to assess blood clots and bleeding events. An additional questionnaire at 1 year evaluates quality of life and joint function for those who experienced complications or a matched group. No extra hospital visits are required. Researchers will measure rates of venous thromboembolic events and major bleeding within 90 days, along with other health outcomes and patient-reported quality of life.

Researchers are investigating treatments for adults diagnosed with acute myeloid leukemia AML or MDSAML that have a mutation in the IDH1 gene and who cannot undergo intensive chemotherapy. The study evaluates whether adding the drug venetoclax to the existing standard treatment of ivosidenib and azacitidine improves patient outcomes compared to a placebo. The safety and effectiveness of venetoclax are key focuses of this phase 3 trial. Participants receive either venetoclax or a placebo alongside ivosidenib and azacitidine. Treatments are given in continuous 28-day cycles and continue until disease relapse, progression, unacceptable side effects, death, withdrawal, or other protocol-defined reasons for stopping. The trial uses a triple-blind, randomized design to fairly compare the two treatment groups. During the study, researchers will monitor event-free survival as the primary outcome, assessing patients for signs of disease control or progression up to 12 months after the last patient is included. Secondary measures include overall survival, response rates, transfusion independence, and the duration and timing of responses. Participant involvement includes regular assessments, blood tests, and monitoring for side effects throughout the treatment period and follow-up.

Researchers are investigating whether chemotherapy can be safely skipped for patients with certain favorable features of low stage triple-negative breast cancer after surgery and radiation. The study aims to see if avoiding chemotherapy improves patients quality of life. Participants decide with their doctors whether to have chemotherapy or not as part of their treatment. Participants receive surgery and radiotherapy based on local or national guidelines. One group will have chemotherapy omitted, while another group will receive chemotherapy in addition to surgery and radiotherapy. The study compares these two approaches to understand treatment outcomes. Participants will be monitored for up to 96 months to track disease recurrence and survival. Quality of life, fear of recurrence, health worries, and cost effectiveness will be assessed up to 2 years after inclusion. Various questionnaires and clinical evaluations will be used to measure these outcomes and ensure participant safety throughout the study.

Multiple sclerosis MS is a common disease affecting the central nervous system and a leading cause of neurological disability in young adults. Researchers are studying the occurrence of asymptomatic spinal cord lesions in recently diagnosed MS patients starting disease-modifying treatments DMT. This observational study aims to understand how often these silent spinal cord lesions appear, especially when brain MRI shows no new disease activity, and to identify factors that may predict these lesions early in the disease course. Participants will undergo regular brain MRI scans as part of routine care, with additional spinal cord MRI scans collected over 27 months. Blood samples and clinical data will also be gathered, and cerebrospinal fluid markers will be analyzed if available. The study will explore associations between spinal cord lesions and various immune and clinical markers, including B-cell profiles, intrathecal antibody synthesis, and specific blood biomarkers. Patients will be recruited from multiple centers and followed closely to monitor disease activity. During the study, participants will have scheduled MRIs, outpatient visits, and blood collections to track neurological changes and disability progression. Outcome measurements include spinal cord lesion counts, brain MRI activity, disability scales, walking and hand function tests, and urinary symptoms. The research team will use these data to better understand disease activity and potentially improve monitoring strategies. The study will last 27 months, with an option to consider an extension phase based on findings.

Researchers are evaluating the drug opevesostat in a phase 3, randomized, open-label study for men with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with next-generation hormonal agents and taxane-based chemotherapy. The study aims to compare overall survival between participants receiving opevesostat and those receiving alternative treatments, including abiraterone acetate or enzalutamide. The research focuses on participants with specific androgen receptor mutations to determine if opevesostat provides better outcomes. Participants are assigned to one of two groups one group receives opevesostat 5 mg orally twice daily along with dexamethasone and fludrocortisone acetate daily, with hydrocortisone available as rescue medication. The other group receives either abiraterone acetate 1000 mg daily plus prednisone 5 mg twice daily or enzalutamide 160 mg daily. Treatments continue until disease progression, with prior prednisone use replaced by hydrocortisone in later protocol versions. During the study, participants undergo regular assessments including scans and laboratory tests to monitor prostate cancer progression and treatment effects. Researchers measure overall survival and several secondary outcomes such as progression-free survival, response duration, pain progression, and adverse events for up to approximately 54 months. The study also tracks safety and treatment discontinuation, with ongoing evaluations throughout the treatment period and follow-up.