Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival
时间窗: Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgery
Imaging biomarkers-including relative cerebral blood volume (rCBV), volume (cm³), and radiomic vascular heterogeneity metrics-will be extracted from the peritumoral infiltrated edema (IPE) habitat using the ONCOhabitats platform on preoperative MRI. These biomarkers will be quantitatively assessed for their association with overall survival. Overall survival is defined as the time from surgical resection to death from any cause, with a follow-up of up to 24 months. Statistical analysis will include Kaplan-Meier survival estimation and Cox proportional hazards regression models.
次要结局
- Gene Expression Profiles in the IPE Region Associated With Poor Response to Immunotherapy in IDH-Wildtype Glioblastoma(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(Tissue samples collected at the time of surgical resection)
- Levels of Immunosuppressive Gene Expression in MRI-Derived Habitats (IPE, HAT, VPE)(Tissue samples collected at the time of surgical resection)
- Association Between Perfusion Imaging Biomarkers and Molecular Markers in IDH-Wildtype Glioblastoma(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(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(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(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(MGMT methylation status assessed at baseline; clinical follow-up up to 24 months)
研究者
Juan M Garcia-Gomez
Full professor
Universitat Politècnica de València