Levanger

This research aims to evaluate the usefulness of a Deep Neural Network (DNN) in analyzing mediastinal and hilar lymph nodes during Endobronchial Ultrasound (EBUS) procedures. The study focuses on whether the DNN can accurately identify lymph nodes and blood vessels seen with EBUS, which is important for lung cancer diagnosis and treatment. It is a multi-center, prospective feasibility study designed to explore these capabilities in a clinical setting. The study involves training the DNN model on ultrasound images that are labeled to show lymph nodes and blood vessels. The first part of the study will assess the DNN's ability to segment lymph nodes and vessels using both postoperative processed images and static EBUS images. The second part will evaluate the real-time use of the DNN during EBUS procedures. The intervention includes a machine learning algorithm device that runs on EBUS images to label mediastinal lymph nodes and their levels during the procedure. Participants will be involved in EBUS imaging where the DNN assists in identifying lymph nodes. The primary outcome measured is the capability of the DNN after 8 months. Researchers will collect and analyze ultrasound images during standard EBUS procedures to assess the accuracy and feasibility of this AI-assisted method. The study includes adults aged 18 years and older referred for evaluation of enlarged mediastinal and hilar lymph nodes. Safety and suitability for participation will be monitored throughout the study.

Researchers are evaluating the usefulness of circulating tumor DNA (ctDNA) markers found in blood as a liquid biopsy tool for diagnosing, predicting outcomes, and monitoring colorectal cancer. The study focuses on whether a panel of ctDNA markers can identify colorectal cancer patients among those scheduled for colonoscopy and how the characteristics of these markers relate to different colorectal cancer subtypes and their clinical progression. Participants will provide a blood sample and complete a questionnaire when they join the study. For patients diagnosed with colorectal cancer, additional blood samples will be collected during routine treatment and follow-up visits. The main intervention involves using a liquid biopsy based on ctDNA markers to assess colorectal cancer and related conditions. Throughout the study, researchers will evaluate the presence of colorectal cancer, colorectal adenoma, and inflammatory bowel disease within three months after colonoscopy. Participants will be followed closely to monitor these outcomes and the ctDNA markers over time. The study involves blood tests, questionnaires, and colonoscopy to gather necessary data and track disease status and treatment responses.

Researchers are investigating the effectiveness of approved anti-cancer drugs used outside their usual indications for patients with advanced cancer who have specific molecular changes identified through genetic testing. This nationwide, phase 2 study in Norway uses a combined umbrella and basket design to explore drug and biomarker combinations across different cancer types. Biological samples will be collected at diagnosis, during treatment, and if the disease progresses to better understand factors affecting drug response and resistance. Patients eligible for this study have advanced cancer that has been previously treated with standard therapies and have acceptable organ function and performance status. Treatment is guided by molecular testing results and recommendations from a national tumor board. Patients receive drugs matched to their tumor's molecular profile, with treatment eligibility confirmed before starting. New patient groups may be opened if no suitable cohort exists. The drug Atezolizumab is among those evaluated, administered according to protocol-specific criteria. Participants will be closely monitored for tumor response, survival, treatment duration, and side effects including serious toxicities. They will undergo molecular testing including whole genome sequencing from tumor biopsies and liquid biopsies. Data on treatment outcomes and molecular markers will be collected and reported to national cancer registries. Patients not enrolled in treatment cohorts will be followed for 16 weeks to track disease progression and survival, with long-term follow-up planned through national health databases.

Prostate cancer is the most common non-skin cancer in men and is often suspected after an elevated prostate-specific antigen (PSA) blood test. This trial evaluates whether using multivariable risk stratification tools, specifically risk calculators from the European Randomised Study of Screening for Prostate Cancer, can detect clinically significant prostate cancer as well as the current standard practice of performing an MRI on all men with suspected prostate cancer. The study aims to determine if these risk calculators can safely reduce the number of MRIs and biopsies needed, while also assessing their cost-effectiveness and impact on men's health-related quality of life. All men in the study undergo risk assessment using the ERSPC risk calculators to decide if they need an MRI or biopsy. The trial compares this risk stratification approach to the current practice of performing MRI in all men with elevated PSA levels. The study includes men aged 50 to 75 years who have suspected localized prostate cancer, a suspicious digital rectal exam, and PSA levels between 3 and 20 ng/ml. Men with higher PSA levels, advanced cancer signs, prior prostate cancer diagnosis, or contraindications to MRI or biopsy are excluded. Participants are monitored during the initial diagnostic work-up of up to 6 weeks to detect clinically significant prostate cancer. Researchers measure how well the risk calculators identify significant cancer compared to MRI-based diagnosis, as well as the number of biopsies and MRIs performed, health anxiety, quality of life, and cost-effectiveness. The study collects clinical data, prostate examinations, PSA levels, and follows participants through diagnostic decisions and outcomes during the trial period.

Researchers are evaluating a psychoeducational course designed for patients at increased risk of suicide following an episode of imminent suicide risk. The study compares this course to a control group receiving one individual session focused on safety planning, both alongside treatment as usual (TAU). The aim is to provide education about suicide-related topics, help patients identify triggers and early warning signs, and develop personalized safety plans to prevent future suicide risk. The trial is a randomized controlled study involving patients admitted to acute psychiatric wards or in contact with outpatient emergency psychiatric teams. Participants are randomly assigned to either a group-based psychoeducational course or an individual therapy session. The course consists of four sessions: the first three sessions include information on suicidal thoughts, risk factors, triggers, and safety planning, while the fourth session is for next of kin to review the material and discuss their role in support. The control group receives one individual session focused on suicide risk and safety planning. Both groups continue to receive TAU, which may include medications and other therapies as deemed necessary by their physicians. During the study, participants undergo assessments including self-efficacy, mental pain, and depression questionnaires at baseline and after intervention, as well as at 6, 12, 24, and 60 months follow-up. Data collection and rating at follow-ups are blinded to treatment assignment to reduce bias. The primary outcome measured is self-efficacy immediately after the intervention and at subsequent follow-ups. The study includes monitoring of symptoms and treatment adherence over this extended period to evaluate the intervention's impact on suicide prevention.

Ankle fractures are common injuries, occurring in about 1 in 800 people each year. The deep deltoid ligament plays a crucial role in stabilizing the ankle joint and influences treatment decisions. Researchers aim to find out if repairing the deltoid ligament in unstable ankle fractures leads to better function and may help prevent long-term osteoarthritis compared to treating only the lateral malleolus fracture. This study is a multicenter randomized controlled trial focusing on patients with complex ankle fractures requiring surgery. Participants will be randomly assigned to receive either the standard surgical repair of the lateral malleolus alone or with an additional procedure to suture the deep deltoid ligament. The ligament repair involves a curved incision to access and suture the ligament to an anchor in the talus bone. This treatment may also help compensate for related syndesmotic injuries. The study will compare functional outcomes and ankle stability between these treatments over time. Participants will be followed for up to five years after injury, with key assessments at one and two years, including patient-reported function and radiological evaluations of ankle stability. Data on function at five years will also be collected. Researchers will monitor recovery, ankle joint condition, and any signs of arthritis to determine if ligament repair offers long-term benefits. The total participation time involves initial treatment and multiple follow-up visits for evaluations and imaging.

Researchers are studying the effectiveness and potential complications of new immunotherapies used to treat multiple myeloma, plasma cell leukemia, and AL amyloidosis in routine care settings in Norway. The goal is to fill gaps in knowledge, support future clinical trials, and help develop guidelines for monitoring and managing side effects to improve patient survival and quality of life. This observational study focuses on patients receiving these treatments as part of regular medical care. The treatments studied include Teclistamab, Elranatamab, Talquetamab, Idecabtagene vicleucel, and Ciltacabtagene autoleucel. The study tracks how these therapies are used and dosed in real-world settings outside clinical trials. Patients receive these immunotherapies as planned by their healthcare providers, and their treatment details and outcomes are observed over time. Participants will be followed for up to ten years from the start of treatment. Researchers will gather data on overall response rates, progression-free survival, time to next treatment, and overall survival. They will also monitor the frequency and severity of adverse events, infection patterns, antibiotic resistance, and use of antimicrobial prevention methods. Data collection includes real-world clinical outcomes to better understand the long-term effects and safety of these immunotherapies.

Researchers are evaluating whether treating minimal residual disease (MRD) relapse after initial treatment can extend progression-free survival and overall survival in patients with multiple myeloma. This study focuses on patients who achieve MRD negativity following first-line treatment, including autologous stem cell transplantation, as part of a phase II/III trial conducted according to Norwegian standard care. The trial aims to create a uniform group of MRD-negative patients who will then enter a randomized phase to compare treatment timings. In the first phase, 391 newly diagnosed multiple myeloma patients eligible for high-dose therapy and stem cell support receive standard first-line treatment with bortezomib, lenalidomide, and dexamethasone in four pre-transplant induction cycles and four post-transplant consolidation cycles. After induction, patients undergo a single or tandem autologous stem cell transplant based on response and toxicity. Those achieving MRD-negative complete response will be randomized into two groups: one starting second-line treatment at MRD relapse and the other starting at clinical progressive disease. Both groups receive carfilzomib, dexamethasone, and daratumumab in 28-day cycles until disease progression or unacceptable side effects. Participants will have regular monitoring including MRD assessments every four months in the early treatment arm and standard follow-up in the other. Additional MRD evaluations occur at specific timepoints during second-line therapy. Researchers will measure progression-free survival over 10 years and overall survival over 11 years, as well as MRD negativity status shortly after consolidation treatment. The study duration and close clinical monitoring aim to evaluate the timing of treatment initiation and its impact on patient outcomes.