Clinical trial · Interventional
Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas
Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation
- 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 study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas. Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively. Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.
Conditions
Conditions (1)
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 Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2HG Spectroscopy Scan | Device | — | UNRESOLVED |
| MR Perfusion Scan | Device | — | UNRESOLVED |
| Standard of Care Intraoperative MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1, Group A (contrast enhancing tumor)
- description
- Group A patients will undergo standard tumor preoperative imaging and MR perfusion scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with MR perfusion scan during surgical resection.
- interventionNames
- Device: MR Perfusion Scan
- type
- EXPERIMENTAL
- label
- Cohort 1, Group B (non-enhancing tumor)
- description
- Group B patients will undergo standard tumor preoperative imaging and 2HG spectroscopy scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with 2HG spectroscopy scan during surgical resection.
- interventionNames
- Device: 2HG Spectroscopy Scan
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Suspected glioma (grade II, III, or IV) * Preoperative MR perfusion (enhancing tumors) * Preoperative MR 2-HG spectroscopy (nonenhancing tumors) * Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care * Karnofsky performance status ≥ 60 * Life expectancy \> 12 weeks * Cohort 1: Ability to comply with study and follow-up procedures * Cohort 2: Ability to comply with study procedures Exclusion Criteria: * Prior diagnosis of intracranial glioma * Other malignancy with expected need for systemic therapy within 3 years * Inability to have 6000 grays of radiation to the brain * Need for urgent palliative intervention for primary disease (e.g., impending herniation) * Evidence of bleeding diathesis or coagulopathy * History of intracerebral abscess within 6 months prior to Day 0 * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study * Pregnant females * Subjects unable to undergo an MRI with contrast
References
Publications (42)
- BACKGROUNDJensen RL, Mumert ML, Gillespie DL, Kinney AY, Schabel MC, Salzman KL. Preoperative dynamic contrast-enhanced MRI correlates with molecular markers of hypoxia and vascularity in specific areas of intratumoral microenvironment and is predictive of patient outcome. Neuro Oncol. 2014 Jan;16(2):280-91. doi: 10.1093/neuonc/not148. Epub 2013 Dec 4. PMID 24305704
- BACKGROUNDChen R, Ravindra VM, Cohen AL, Jensen RL, Salzman KL, Prescot AP, Colman H. Molecular features assisting in diagnosis, surgery, and treatment decision making in low-grade gliomas. Neurosurg Focus. 2015 Mar;38(3):E2. doi: 10.3171/2015.1.FOCUS14745. PMID 25727224
- BACKGROUNDKarsy M, Neil JA, Guan J, Mahan MA, Colman H, Jensen RL. A practical review of prognostic correlations of molecular biomarkers in glioblastoma. Neurosurg Focus. 2015 Mar;38(3):E4. doi: 10.3171/2015.1.FOCUS14755. PMID 25727226
- BACKGROUNDHuse JT, Holland EC. Targeting brain cancer: advances in the molecular pathology of malignant glioma and medulloblastoma. Nat Rev Cancer. 2010 May;10(5):319-31. doi: 10.1038/nrc2818. PMID 20414201
- BACKGROUNDKarsy M, Huang T, Kleinman G, Karpel-Massler G. Molecular, histopathological, and genomic variants of glioblastoma. Front Biosci (Landmark Ed). 2014 Jun 1;19(7):1065-87. doi: 10.2741/4268. PMID 24896337
- BACKGROUNDStupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.