3D Decision Support Tool for Brain Tumour Surgery Development and Validation: Observational Study

Summary

This observational study (STRATUM-OS) aims to collect the necessary data from a cohort of patients with planned surgery for suspected intra-axial malignant brain tumours (both primary and secondary) following the standard surgical procedure established in current clinical protocols. These data will serve two primary purposes:

i) To gather multimodal data (pre, intra and postoperative) essential for the development and technical validation of a 3D decision support tool for brain surgery guidance and diagnostics integrating augmented reality and multimodal data processing powered by artificial intelligence algorithms (called STRATUM tool);

ii) To collect outcome measures that will facilitate a subsequent comparative study (a non-randomized controlled clinical trial, called STRATUM-NRCCT) assessing the standard procedure alone versus the standard procedure augmented with the STRATUM tool. Patients from STRATUM-OS will act as a historical control group in the subsequent historically controlled clinical trial (STRATUM-NRCCT), which will be performed once STRATUM-OS has been completed.

In STRATUM-OS patients will receive standard care as per established clinical protocols, with no modification to their treatment. However, patients will be asked to grant access to their clinical information, complete questionnaires, and provide relevant pre, intra and postoperative information related to the surgical intervention. Data will be gathered from multiple sources, such as the Electronic Health Records (EHR), patient completed questionnaires, interviews, and reports from healthcare professionals involved in the surgical procedure. Additionally, intraoperative data will be collected from the different devices in the operating room.

Conditions

• Brain (Nervous System) Cancers
• Brain Tumor, Primary

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Hospital Universitario de Gran Canaria Doctor Negrín

  collaborator UNKNOWN

• Fundación para la Investigación Biomédica del Hospital 12 de Octubre

  collaborator UNKNOWN

• Fundación Canaria de Investigación Sanitaria

  lead OTHER

Principal Investigators

• Juan F. Piñeiro-Marti, MD, PhD · Dept. of Neurosurgery, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain

• Alfonso Lagares, MD, PhD · 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 · Dept. of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden

• Himar Fabelo, MsC, PhD · Research Unit, Hospital Universitario de Gran Canaria Dr. Negrin, Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Las Palmas de Gran Canaria, Spain

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2027-04-30

Completion

2027-04-30