{
  "abstract": "Introduction Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.Methods and analysis This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.Ethics and dissemination The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.Trial registration number NCT07036783.",
  "authors": [
    {
      "affiliations": [
        "Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Research Unit, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Institute for Applied Microelectronics, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Instituto de Investigación Sanitaria de Canarias (IISC), Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Himar Fabelo"
    },
    {
      "affiliations": [
        "Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Instituto de Investigación Sanitaria de Canarias (IISC), Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Servicio de Evaluación y Planificación del Servicio Canario de la Salud, Servicio Canario de Salud, Santa Cruz de Tenerife, Tenerife, Spain",
        "Red de Investigación en Cronicidad Atención Primaria y Prevención y Promoción de la Salud, El Rosario, Tenerife, Spain"
      ],
      "name": "Yolanda Ramallo-Fariña"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Jesús Morera"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Juan F. Piñeiro"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Hospital Universitario 12 de Octubre, Madrid, Community of Madrid, Spain",
        "Department of Surgery, Medicine Faculty, Universidad Complutense de Madrid, Madrid, Spain",
        "Instituto de Investigaciones Sanitarias (imas12), Madrid, Spain"
      ],
      "name": "Alfonso Lagares"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Hospital Universitario 12 de Octubre, Madrid, Community of Madrid, Spain",
        "Department of Surgery, Medicine Faculty, Universidad Complutense de Madrid, Madrid, Spain",
        "Instituto de Investigaciones Sanitarias (imas12), Madrid, Spain"
      ],
      "name": "Luis Jiménez-Roldán"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden"
      ],
      "name": "Gustav Burström"
    },
    {
      "affiliations": [
        "Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Instituto de Investigación Sanitaria de Canarias (IISC), Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Servicio de Evaluación del Servicio Canario de la Salud, Servicio Canario de Salud, Santa Cruz de Tenerife, Tenerife, Spain"
      ],
      "name": "Miguel A. García-Bello"
    },
    {
      "affiliations": [
        "Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Instituto de Investigación Sanitaria de Canarias (IISC), Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Servicio de Evaluación del Servicio Canario de la Salud, Servicio Canario de Salud, Santa Cruz de Tenerife, Tenerife, Spain"
      ],
      "name": "Lidia García-Pérez"
    },
    {
      "affiliations": [
        "Department of Radiology, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Rebeca Falero"
    },
    {
      "affiliations": [
        "Department of Pathological Anatomy, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Marta González"
    },
    {
      "affiliations": [
        "Department of Radiology, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Sebastián Duque"
    },
    {
      "affiliations": [
        "Clinical Trials Unit, Pharmacology Department, Hospital Universitario de Canarias, La Laguna, Tenerife, Spain"
      ],
      "name": "Consuelo Rodriguez-Jimenez"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "María Hernández"
    },
    {
      "affiliations": [
        "Department of Pathological Anatomy, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Julio J Delgado-Sánchez"
    },
    {
      "affiliations": [
        "Department of Pathological Anatomy, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Ana B Paredes"
    },
    {
      "affiliations": [
        "Department of Radiology, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Guillermo Hernández"
    },
    {
      "affiliations": [
        "Department of Radiology, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Pedro Ponce"
    },
    {
      "affiliations": [
        "Institute for Applied Microelectronics, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Raquel León"
    },
    {
      "affiliations": [
        "Research Unit, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Jesús M González-Martín"
    },
    {
      "affiliations": [
        "Research Unit, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Francisco Rodríguez-Esparragón"
    },
    {
      "affiliations": [
        "Institute for Applied Microelectronics, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Gustavo M Callicó"
    },
    {
      "affiliations": [
        "Instituto de Investigación Sanitaria de Canarias (IISC), Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Instituto de Investigaciones Biomédicas y Sanitarias, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, CN, Spain",
        "Complejo Hospitalario Universitario Insular Materno-Infantil de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Ana M Wägner"
    },
    {
      "affiliations": [
        "Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Research Unit, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain",
        "Instituto de Investigación Sanitaria de Canarias (IISC), Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Bernardino Clavo"
    },
    {
      "affiliations": [],
      "name": "STRATUM Consortium"
    }
  ],
  "title": "STRATUM-OS: first step in the development and validation of the STRATUM tool based on multimodal data processing to assist surgery in patients affected by intra-axial brain tumours – observational study protocol",
  "uid": "a2732f3f-6322-559b-af9d-a4111b36fc0a"
}