Clinical Research Directory

PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors

Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings. Despite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care. The PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a "caregiver compass" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway. PIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care. The study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention. The primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures. In addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.

Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment

Locoregional, intracavitary radioimmunotherapy (iRIT) with a newly developed radioimmunoconjugate (Lu-177 labeled 6A10-Fab-fragments) will be used to prevent or postpone tumour recurrence in patients with GBM following standard therapy . Following study objectives will be analyzed: * Determining the Maximum Tolerated Dose (MTD) * Determining safety by assessing all new neurological, hematological and other AEs CTC grade 2 or higher * Determining absorbed dose to the 2 cm shell of the resection cavity (based on a series of SPECT/CTs of the head 2h,24h,48h, 72h p.i. and on day 5-7) * Determining absorbed dose values for the kidneys, the liver, the active marrow (based on a series of SPECT/CTs of the abdomen 2h,24h,48h, 72h p.i. and on day 5-7) * Determining 24 weeks Progression-Free-Survival (PFS), defined from the day of inclusion

FCI-Glioblastoma Study

The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can tell the difference between tumour growth (progression) and 'pseudo-progression' (which looks like tumour but is not cancerous tissue) in patients with glioblastoma. The main question it aims to answer is: • Can FCI differentiate glioblastoma progression from pseudo-progression? Participants will undergo a standard MRI scan and an FCI scan, three times during the study. One before starting adjuvant chemotherapy, another one after three cycles and one at the end of treatment.

Clinical Study on the Safety and Immunogenicity of Specific Cancer Vaccines in Preventing Recurrence of Glioblastoma

This study evaluates the safety and specific antitumor immune responses of mRNA vaccines GV-108 and GV-907 in IDH-wildtype glioblastoma patients.