Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)

Официальное название

Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)

Обзор

The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma. The study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making. The primary research questions are: * Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis? * Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and immunotherapy? Participants will: * Be adults diagnosed with high-grade glioma who are scheduled for surgical tumor resection * Undergo preoperative MRI processed with ONCOhabitats to segment the tumor into four biological habitats (HAT, LAT, IPE, and VPE) * Provide tissue samples from each habitat when feasible, based on surgical and clinical considerations Researchers will analyze: * Imaging biomarkers (e.g., relative cerebral blood volume, rCBV) * Molecular and histopathological features (e.g., MGMT promoter methylation, gene expression profiles associated with immunosuppression) * Clinical and survival outcomes This study seeks to enhance glioblastoma characterization and support personalized treatment strategies through the clinical validation of a software platform.

Вмешательства

• Устройство The ONCOhabitats software for MRI-based habitat segmentation
  ONCOhabitats is an MRI-based software platform designed to segment IDH-wildtype glioblastomas into four biologically distinct habitats (HAT, LAT, IPE, and VPE) based on vascular heterogeneity. In this study, the software is applied preoperatively to generate imaging biomarkers that guide surgical sampling and are assessed for their ability to predict overall survival and stratify patients accordingly. The intervention includes advanced perfusion imaging processing using the HTS methodology, no

Первичные конечные точки

• Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival [Срок оценки: Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgery]

Вторичные конечные точки (8)

• Gene Expression Profiles in the IPE Region Associated With Poor Response to Immunotherapy in IDH-Wildtype Glioblastoma [Срок оценки: Tissue samples collected at surgery; clinical follow-up for up to 24 months]
• Histopathological Features in Tumor (HAT, LAT) and Edema (IPE, VPE) Habitats Defined by ONCOhabitats in IDH-Wildtype Glioblastoma [Срок оценки: Tissue samples collected at the time of surgical resection]
• Levels of Immunosuppressive Gene Expression in MRI-Derived Habitats (IPE, HAT, VPE) [Срок оценки: Tissue samples collected at the time of surgical resection]
• Association Between Perfusion Imaging Biomarkers and Molecular Markers in IDH-Wildtype Glioblastoma [Срок оценки: MRI performed preoperatively; molecular analysis from tissue samples collected during surgery]
• Predictive Value of Combined Imaging, Histopathological, Molecular, and Cellular Biomarkers in IDH-Wildtype Glioblastoma [Срок оценки: Biomarker data collected at surgery; clinical follow-up up to 24 months post-surgery]
• Stratification Biomarkers for Surgical Resection of the IPE Region or Local Immunotherapy in the Resection Cavity [Срок оценки: Biomarker data collected at surgery; follow-up up to 24 months]
• Patient Stratification Based on MGMT Promoter Methylation Status and rCBV for Response to Temozolomide in IDH-Wildtype Glioblastoma [Срок оценки: MGMT and rCBV data collected at baseline (before treatment); follow-up up to 24 months]
• Correlation Between MGMT Methylation Status Assessed by Immunohistochemistry and MLPA and Response to Temozolomide in IDH-Wildtype Glioblastoma [Срок оценки: MGMT methylation status assessed at baseline; clinical follow-up up to 24 months]

Критерии участия

Критерии включения

• Adults (≥18 years old) at the time of diagnosis
• Radiological diagnosis of high-grade glioma
• Candidates for surgical resection
• Availability of complete preoperative MRI studies, including:
• T1-weighted MRI (pre- and post-gadolinium)
• T2-weighted MRI
• FLAIR (Fluid-Attenuated Inversion Recovery)
• T2\*-weighted DSC perfusion MRI
• Signed informed consent to participate in the clinical study

Критерии исключения

• Patients who do not provide informed consent
• Patients deemed inoperable

Withdrawal criteria:

• MRI data that cannot be processed using ONCOhabitats
• Patient withdraws informed consent at any time

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 5 центров

• Hospital General Universitario Dr. Balmis — Alicante
• Hopsital Universitari Vall d'Hebron — Barcelona
• Hospital Clínico Universitario Virgen de la Arrixaca — Murcia
• Hospital Universitario de Canarias — Santa Cruz de Tenerife
• Hospital Clínic i Universitari de València — Valencia

Публикации

• Juan-Albarracin J, Fuster-Garcia E, Perez-Girbes A, Aparici-Robles F, Alberich-Bayarri A, Revert-Ventura A, Marti-Bonmati L, Garcia-Gomez JM. Glioblastoma: Vascular Habitats Detected at Preoperative Dynamic Susceptibility-weighted Contrast-enhanced Perfusion MR Imaging Predict Survival. Radiology. 2018 Jun;287(3):944-954. doi: 10.1148/radiol.2017170845. Epub 2018 Jan 19. PMID 29357274
• Del Mar Alvarez-Torres M, Juan-Albarracin J, Fuster-Garcia E, Bellvis-Bataller F, Lorente D, Reynes G, Font de Mora J, Aparici-Robles F, Botella C, Munoz-Langa J, Faubel R, Asensio-Cuesta S, Garcia-Ferrando GA, Chelebian E, Auger C, Pineda J, Rovira A, Oleaga L, Molla-Olmos E, Revert AJ, Tshibanda L, Crisi G, Emblem KE, Martin D, Due-Tonnessen P, Meling TR, Filice S, Saez C, Garcia-Gomez JM. Robus PMID 31654541
• Juan-Albarracin J, Fuster-Garcia E, Garcia-Ferrando GA, Garcia-Gomez JM. ONCOhabitats: A system for glioblastoma heterogeneity assessment through MRI. Int J Med Inform. 2019 Aug;128:53-61. doi: 10.1016/j.ijmedinf.2019.05.002. Epub 2019 May 16. PMID 31160012

Идентификаторы

NCT: NCT07111195 · INNEST/2022/087

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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