Clinical trial · Observational
3D Decision Support Tool for Brain Tumour Surgery Development and Validation: Observational Study
Multimodal Data Collection for the Development and Validation of the STRATUM Tool to Assist Surgery in Patients Affected by Brain Tumours: Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain (Nervous System) Cancers | — | UNRESOLVED | — |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Control
- description
- 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.
Primary outcomes (1)
- measure
- STRATUM Tool intraoperative tumour identification against anatomopathological analysis
- timeFrame
- Between 3- and 4-weeks post-surgery for the last patient recruited once definitive histopathological results are available.
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDLouis 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
- BACKGROUNDSanvito 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
- BACKGROUNDBoxerman 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
- BACKGROUNDLeon 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
- BACKGROUNDJakola 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
- BACKGROUNDGerard 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.