Kil

Researchers are studying why up to 25% of children who have surgery for tumors in the posterior fossa area of the brain develop Cerebellar Mutism Syndrome (CMS). This syndrome includes symptoms like loss of speech, low muscle tone, poor coordination, and irritability. The study aims to understand the causes, risk factors, clinical progression, and best treatments for CMS. This is a large, prospective multicenter study involving at least 500 pediatric patients from Nordic countries, with potential for additional countries to join. Patients with tumors in the cerebellum, 4th ventricle, or brainstem planned for surgical removal or biopsy are included. Data is collected before surgery, within 72 hours after surgery, at 1-4 weeks, 2 months, and 12 months post-surgery. Information recorded includes neurological and speech evaluations, surgery details, complications, medications, imaging results, tumor pathology, and genetics. Blood samples for genetic analysis are also collected to explore genetic links to CMS. Patients undergoing repeat surgeries during follow-up restart the evaluation process. Participants undergo detailed neurological and speech assessments at scheduled times up to one year after surgery. Speech samples and neuropsychological tests are analyzed centrally. Researchers monitor the development and progression of CMS, treatment effects, and tumor status through imaging and pathology reports. The study database is managed centrally to ensure high-quality data. The goal is to reduce CMS incidence, improve treatments, and harmonize care for children with posterior fossa brain tumors across Nordic countries.

Researchers are evaluating the safety and diagnostic accuracy of a new PET imaging agent called 64Cu-DOTA-AE105 to assess the aggressiveness of localized, untreated prostate cancer. This agent targets uPAR-expressing cells in tumors and may serve as an alternative or supplement to repeated biopsies in patients under active surveillance with low-risk prostate cancer. The study is a Phase 2 clinical trial focused on patients with biopsy-confirmed prostate adenocarcinoma of ISUP grade 1 to 3. The trial has two parts. In the first part, participants receive two injections of the test drug on separate days spaced 8 days apart. Each injection is followed by PET/CT scanning of the prostate to capture images, along with health assessments including ECG and blood and urine tests before and after imaging. In the second part, participants receive one injection and undergo the same scanning and testing procedures. The agent is delivered intravenously and binds to tumor cells to allow visualization with PET imaging. Participants will undergo evaluations before and after each injection and scan, including health status checks, heart function monitoring via ECG, and laboratory tests of blood and urine. The main outcome measured is the maximum standard uptake value (SUVmax) at specified times after injection, which reflects the imaging agent's uptake in the tumor. The trial aims to determine if this imaging test can accurately classify prostate cancer grades non-invasively, potentially reducing the need for repeated biopsies. Male patients aged 18 years and older with low-grade localized prostate cancer are eligible to participate.