3D Decision Support Tool for Brain Tumour Surgery Development and Validation: Observational Study
Launched by FUNDACIÓN CANARIA DE INVESTIGACIÓN SANITARIA · Jun 17, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical study is focused on collecting important information from patients who are scheduled to have surgery for certain types of brain tumors. These tumors are located inside the brain and can be either primary (starting in the brain) or secondary (spread from other parts of the body). The goal is to use this information to help develop and test a new 3D tool that uses advanced technology, like artificial intelligence and augmented reality, to assist surgeons during brain tumor operations. This tool aims to improve how surgeries are planned and performed in the future.
Adults aged 18 and over who are about to have surgery for these brain tumors may be eligible to take part. If you join, your treatment won’t change—you will receive the standard care recommended by doctors. However, the study team will ask to access your medical records, ask you some questions, and collect information before, during, and after your surgery. This includes details from medical devices used during the operation. The information gathered will help compare current surgical methods with the new 3D tool in future studies. It’s important to know that this study is observational, meaning it only collects data without changing your treatment, and it hasn’t started recruiting patients yet.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients (≥18 y/o).
- • Patients with planned surgery for suspected intraaxial malignant brain tumours (both primary and secondary) at any of the participating clinical institutions.
- Exclusion Criteria:
- • Inability to deliver informed consent (unless provided by the tutor).
- • Participants in this study who have already undergone brain surgery during STRATUM-OS and need a revision surgery.
About Fundación Canaria De Investigación Sanitaria
The Fundación Canaria de Investigación Sanitaria (FCIS) is a prominent research foundation based in the Canary Islands, dedicated to advancing medical science and improving healthcare outcomes through innovative clinical trials. Committed to fostering collaboration among researchers, healthcare professionals, and institutions, FCIS focuses on the development and implementation of cutting-edge research initiatives that address critical health challenges. By prioritizing patient-centric approaches and ethical standards, the foundation aims to contribute significantly to the field of medical research, enhancing the quality of care and promoting public health in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Juan F. Piñeiro-Marti, MD, PhD
Principal Investigator
Dept. of Neurosurgery, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain
Alfonso Lagares, MD, PhD
Principal Investigator
Dept. of Neurosurgery, Hospital Universitario 12 Octubre, Dept. of Surgery, Medicine Faculty, Universidad Complutense de Madrid, Instituto de Investigaciones Sanitarias (imas12), Madrid, Spain
Gustav Burström, MD, PhD
Principal Investigator
Dept. of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden
Himar Fabelo, MsC, PhD
Study Director
Research Unit, Hospital Universitario de Gran Canaria Dr. Negrin, Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Las Palmas de Gran Canaria, Spain
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported