Trondheim

Researchers are evaluating a new treatment approach for meningiomas that continue to grow despite local therapies like surgery and radiotherapy. This trial focuses on the precision medicine concept of combining molecular imaging for patient selection with targeted treatment using a radioligand called 177Lu-DOTATATE. The study builds on evidence showing high expression of somatostatin receptors in meningiomas and prior success of this radioligand therapy in other tumors, aiming to explore its use in refractory meningiomas in a randomized Phase II study. Participants are randomly assigned to receive either the investigational treatment 177Lu-DOTATATE given by intravenous injection or the local standard of care, which may include treatment or observation as decided by their doctor. The trial involves baseline PET imaging to confirm somatostatin receptor positivity and follows patients after treatment. This design allows researchers to compare the effects of the new therapy against current practices in managing recurrent meningioma. During the study, participants undergo assessments including cranial MRI scans to measure tumor status and PET imaging for receptor evaluation. Blood tests are performed to monitor organ function and electrolytes before and during treatment. The main outcome measured is progression-free survival, tracking the time from randomization until disease progression or death, with follow-up for up to two years. Safety and treatment adherence are closely monitored throughout the study period.

Researchers are evaluating the use of 68Ga/177Lu-PSMA theranostics as a treatment option for patients in Norway with recurrent grade 3 and grade 4 gliomas, a group with very limited treatment options and poor survival. This pilot clinical study aims to improve current diagnostic and therapeutic approaches by introducing a novel radionuclide therapy that may enhance overall survival and quality of life for these patients. Patients who show high tumor uptake of 68Ga-PSMA on a diagnostic PET/MRI scan during screening can receive up to 3 cycles of 177Lu-PSMA radionuclide therapy, with a possible extension to 6 cycles. After each treatment cycle, SPECT/CT scans are performed to calculate the radiation dose delivered. Therapeutic effects are monitored through repeated 68Ga-PSMA PET/MRI scans, quality-of-life questionnaires, and clinical exams during treatment and for up to 1.5 years after starting therapy. Participants will be closely followed with clinical evaluations and imaging to assess progression-free and overall survival. Safety is monitored by recording adverse events on the first day and 6 months after the end of therapy, with efficacy evaluated at 6 months and 1 year after therapy begins. The total involvement includes screening, treatment cycles, and extended follow-up to capture long-term outcomes and tolerability of this radionuclide therapy.

Researchers are evaluating a behavioral 3-day course called the Lightning Process (LP) for adults with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), a condition that can severely limit function and quality of life. The study aims to investigate both positive and negative effects of this course on symptoms, disability, and quality of life, as well as long-term work participation. This randomized controlled trial addresses the growing patient population in Norway and the significant social and economic burden CFS/ME presents to individuals and society. Participants will be randomly assigned to either receive the 3-day LP course immediately or to a waiting list group that receives treatment as usual for the first 10 weeks before attending the course. The LP course is based on stress theory, Positive Psychology, and techniques for regulating thoughts, feelings, and behavior to positively influence physical health. Any adverse events during or after the course will be managed according to the study protocol. During the study, researchers will assess physical function 10 weeks after the 3-day course. Participants will be monitored through questionnaires and evaluations to measure symptoms, disability, and quality of life, as well as work participation over the long term. The total participation period includes the initial course, follow-up assessments, and monitoring for potential side effects or benefits.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

This research investigates the long-term effects of mirikizumab in children and adolescents aged 2 to 19 years with moderate-to-severe ulcerative colitis or Crohn's disease. The study is designed as a Phase 3, multicenter, open-label extension trial aiming to assess the ongoing safety and efficacy of this treatment in pediatric participants. It includes those who have completed previous related studies and are expected to benefit from continued mirikizumab treatment. Participants will receive mirikizumab either by subcutaneous injection or intravenous infusion as part of this extended treatment. The study may last approximately 172 weeks and involve up to 44 visits over this period. There is also a possibility for participants to continue receiving treatment through a Continued Access Period after the main study. Throughout the study, participants will be regularly monitored with clinical assessments to determine remission status using the Modified Mayo Score for ulcerative colitis and the Pediatric Crohn's Disease Activity Index for Crohn's disease at week 52. Safety and efficacy will be closely followed, including the evaluation of any adverse events or changes in disease activity, ensuring comprehensive long-term observation.

Researchers are evaluating a digital support system called Evira designed to help treat childhood obesity, a growing global health concern linked to serious health problems like type 2 diabetes and high blood pressure. The study aims to see if adding Evira to the usual lifestyle treatment can improve outcomes for children and adolescents aged 4 to 17 years with obesity. Evira offers daily weight monitoring at home using a special scale connected to a mobile app, allowing parents and clinicians to closely track weight changes and communicate easily. Participants will be randomly assigned to one of two groups: the intervention group receives Evira support alongside standard lifestyle treatment, while the control group receives only the standard lifestyle care without restrictions on visits or clinical support. The 12-month study begins with information and training on using Evira, including installing scales and apps for parents and possibly the child. The intervention includes personalized weight loss targets for the first three months, with continuous monitoring and communication through the app and website. Throughout the study, all children will undergo clinical exams assessing puberty, heart and lung health, thyroid function, skin, and abdomen, as well as measurements of weight, height, and blood pressure. Blood tests may be done as needed. Participants and parents will complete questionnaires on quality of life, eating behaviors, and treatment satisfaction. Researchers will track weight changes over 12 months and collect safety and background information via electronic forms to evaluate the effectiveness of adding Evira to standard obesity care.

Researchers are investigating a new clinical pathway for managing borderline resectable and locally advanced pancreatic cancer in Norway. This nationwide prospective study aims to evaluate how often surgery can successfully remove tumors and assess survival rates following primary chemotherapy. The goal is to achieve a 50% resection rate for borderline resectable pancreatic cancer and 15% for locally advanced cases, with targeted survival and complication rates after surgery based on national guidelines. Patients receive chemotherapy according to Norwegian standards, preferably with mFOLFIRINOX or gemcitabine-nab-paclitaxel. Surgery is planned within four weeks after completing chemotherapy, involving different types of pancreatic removal procedures, potentially including vascular resections. Diagnostic steps include endoscopic ultrasound biopsy for tumor confirmation and molecular analysis, with optional PET/CT scans at baseline and after at least two months of chemotherapy to assess treatment response. Participants undergo careful evaluations including histological diagnosis, imaging, and monitoring throughout treatment. The main measure of success is the rate of tumor removal by surgery from November 2024 to December 2027. Researchers also track survival, complications, and treatment outcomes to better understand the effectiveness of this personalized approach over time.

Researchers are studying an intermittent dosing strategy of ibrutinib, a drug approved for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Ibrutinib is usually given daily at a continuous dose of 420 mg until the disease progresses. Due to increasing drug costs and some patients maintaining disease control even after stopping ibrutinib because of side effects, this pilot study explores whether cycling ibrutinib on and off could be effective and reduce costs and side effects. The study also looks at long-term effects on mutations related to the drug's target, Brutonb4s tyrosine kinase (BTK).

Researchers are investigating how machine learning (ML) models can predict the effectiveness of migraine preventive treatments in adults with episodic or chronic migraine. The study aims to identify personal, headache-related, and other health features of migraine patients to understand how these factors influence treatment response. The goal is to reduce the time needed to find an effective preventive therapy by using ML to predict individual treatment effects compared to actual outcomes. Participants will receive standard migraine preventive treatments prescribed by their doctors without interference from researchers. The study involves monitoring headache days for 4 weeks before starting treatment and then for 12 weeks after treatment begins, divided into 28-day periods. If a participant experiences a 50% or greater reduction in monthly headache days, the preventive treatment is considered effective. Some participants may have an optional second 12-week treatment period with follow-up. During the study, participants will have a phone consultation at the start and follow-up calls after each treatment period to assess outcomes. Researchers will collect data on headache frequency and personal factors to compare predicted treatment effects from ML models with actual results. The total study duration for each participant can be up to 28 weeks, allowing researchers to evaluate the accuracy and usefulness of ML in guiding migraine treatment choices.