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

NCT07036783 | Not Yet Recruiting DMC

• 2 other identifiers: STRATUM-OS101137416
• Study Type: observational
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hyperspectral Imaging; Brain Tumour; Neurosurgery; Multimodal imaging

Outcome Measures

Primary Outcomes (1)

• STRATUM Tool intraoperative tumour identification against anatomopathological analysis

  The primary outcome measure consists of the histopathological classification of resected tissue samples as "tumour" or "non-tumour", which will serve as the reference standard for technical validation. The STRATUM tool's performance in intraoperative tumour tissue identification will be evaluated against this reference using a three-way data partitioning approach (training, validation, and test sets), with evaluation metrics including sensitivity, specificity, positive and negative predictive values, and/or receiver operating characteristic (ROC) curve analysis. These performance metrics will be calculated at the tissue sample level using the test set.

  Between 3- and 4-weeks post-surgery for the last patient recruited once definitive histopathological results are available.

Secondary Outcomes (1)

• STRATUM Tool intraoperative identification of Contrast Enhancing Tumour (CET) or non-Contrast Enhancing Tumour (nCET) (FLAIR positive)

  Between 3- and 4-weeks post-surgery for the last patient recruited, following completion and assessment of the post-operative MRI.

Other Outcomes (1)

• Data collection for technical validation and the generation of a historical control group

  From enrollment to the end of follow-up at 6 months.

Study Arms (1)

Control

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participantion in this study will be proposed to adult patients with planned surgery for suspected intraaxial malignant brain tumours (both primary and secondary). Patients will be recruited at the 3 participant clinical sites: * Hospital Universitario de Gran Canaria Doctor Negrin (HUGCDN), Las Palmas de Gran Canaria, Spain; * Karolinska University Hospital (KUH), Solna, Sweden; * Hospital Universitario 12 de Octubre (HU12O), Madrid, Spain; Recruitment will be performed via consecutive inclusion of subjects fulfilling the inclusion criteria and none of the exclusion criteria at the participating clinical institutions.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Canaria de Investigación Sanitaria: lead
• Karolinska University Hospital: collaborator
• Hospital Universitario de Gran Canaria Doctor Negrín: collaborator
• Fundación para la Investigación Biomédica del Hospital 12 de Octubre: collaborator

Related Publications (11)

• Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.

  PMID: 34185076 BACKGROUND

• Sanvito F, Kaufmann TJ, Cloughesy TF, Wen PY, Ellingson BM. Standardized brain tumor imaging protocols for clinical trials: current recommendations and tips for integration. Front Radiol. 2023 Dec 13;3:1267615. doi: 10.3389/fradi.2023.1267615. eCollection 2023.

  PMID: 38152383 BACKGROUND

• Boxerman JL, Quarles CC, Hu LS, Erickson BJ, Gerstner ER, Smits M, Kaufmann TJ, Barboriak DP, Huang RH, Wick W, Weller M, Galanis E, Kalpathy-Cramer J, Shankar L, Jacobs P, Chung C, van den Bent MJ, Chang S, Al Yung WK, Cloughesy TF, Wen PY, Gilbert MR, Rosen BR, Ellingson BM, Schmainda KM; Jumpstarting Brain Tumor Drug Development Coalition Imaging Standardization Steering Committee. Consensus recommendations for a dynamic susceptibility contrast MRI protocol for use in high-grade gliomas. Neuro Oncol. 2020 Sep 29;22(9):1262-1275. doi: 10.1093/neuonc/noaa141.

  PMID: 32516388 BACKGROUND

• Leon R, Fabelo H, Ortega S, Cruz-Guerrero IA, Campos-Delgado DU, Szolna A, Pineiro JF, Espino C, O'Shanahan AJ, Hernandez M, Carrera D, Bisshopp S, Sosa C, Balea-Fernandez FJ, Morera J, Clavo B, Callico GM. Hyperspectral imaging benchmark based on machine learning for intraoperative brain tumour detection. NPJ Precis Oncol. 2023 Nov 14;7(1):119. doi: 10.1038/s41698-023-00475-9.

  PMID: 37964078 BACKGROUND

• Jakola AS, Skjulsvik AJ, Myrmel KS, Sjavik K, Unsgard G, Torp SH, Aaberg K, Berg T, Dai HY, Johnsen K, Kloster R, Solheim O. Surgical resection versus watchful waiting in low-grade gliomas. Ann Oncol. 2017 Aug 1;28(8):1942-1948. doi: 10.1093/annonc/mdx230.

  PMID: 28475680 BACKGROUND

• Gerard IJ, Kersten-Oertel M, Petrecca K, Sirhan D, Hall JA, Collins DL. Brain shift in neuronavigation of brain tumors: A review. Med Image Anal. 2017 Jan;35:403-420. doi: 10.1016/j.media.2016.08.007. Epub 2016 Aug 24.

  PMID: 27585837 BACKGROUND

• GBD 2016 Brain and Other CNS Cancer Collaborators. Global, regional, and national burden of brain and other CNS cancer, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Apr;18(4):376-393. doi: 10.1016/S1474-4422(18)30468-X. Epub 2019 Feb 21.

  PMID: 30797715 BACKGROUND

• Manni F, van der Sommen F, Fabelo H, Zinger S, Shan C, Edstrom E, Elmi-Terander A, Ortega S, Marrero Callico G, de With PHN. Hyperspectral Imaging for Glioblastoma Surgery: Improving Tumor Identification Using a Deep Spectral-Spatial Approach. Sensors (Basel). 2020 Dec 5;20(23):6955. doi: 10.3390/s20236955.

  PMID: 33291409 BACKGROUND

• Fabelo H, Ortega S, Ravi D, Kiran BR, Sosa C, Bulters D, Callico GM, Bulstrode H, Szolna A, Pineiro JF, Kabwama S, Madronal D, Lazcano R, J-O'Shanahan A, Bisshopp S, Hernandez M, Baez A, Yang GZ, Stanciulescu B, Salvador R, Juarez E, Sarmiento R. Spatio-spectral classification of hyperspectral images for brain cancer detection during surgical operations. PLoS One. 2018 Mar 19;13(3):e0193721. doi: 10.1371/journal.pone.0193721. eCollection 2018.

  PMID: 29554126 BACKGROUND

• Fabelo H, Ortega S, Lazcano R, Madronal D, M Callico G, Juarez E, Salvador R, Bulters D, Bulstrode H, Szolna A, Pineiro JF, Sosa C, J O'Shanahan A, Bisshopp S, Hernandez M, Morera J, Ravi D, Kiran BR, Vega A, Baez-Quevedo A, Yang GZ, Stanciulescu B, Sarmiento R. An Intraoperative Visualization System Using Hyperspectral Imaging to Aid in Brain Tumor Delineation. Sensors (Basel). 2018 Feb 1;18(2):430. doi: 10.3390/s18020430.

  PMID: 29389893 BACKGROUND

• Halicek M, Fabelo H, Ortega S, Callico GM, Fei B. In-Vivo and Ex-Vivo Tissue Analysis through Hyperspectral Imaging Techniques: Revealing the Invisible Features of Cancer. Cancers (Basel). 2019 May 30;11(6):756. doi: 10.3390/cancers11060756.

  PMID: 31151223 BACKGROUND

Related Links

• STRATUM Project: 3D Decision Support Tool for Brain Tumor Surgery (101137416)

Biospecimen

Retention: SAMPLES WITH DNA

Samples of brain tumour tissue and samples of adjacent tissue (suspected to be tumour) resected during neurosurgical procedures that will be taken for the subsequent pathological analysis as in the standard neurosurgical workflow.

MeSH Terms

Conditions

Neurologic Manifestations; Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases

Study Officials

• Juan F. Piñeiro-Marti, MD, PhD

  Dept. of Neurosurgery, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain

  PRINCIPAL INVESTIGATOR

• 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

  PRINCIPAL INVESTIGATOR

• Gustav Burström, MD, PhD

  Dept. of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Himar Fabelo, PhD

CONTACT

+34 928457211; hafabelo@fciisc.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available 2 months after the European STRATUM project ending (February 2029) and is expected to be available at least during 5 years after publication (February 2034).
• Access Criteria: Data will be publicly accessible through public repositories (i.e., EU Open Research Repository at Zenodo) to the scientific community.