Clinical trial · Interventional
Study About the Validity of MRS-guided Resection on Prognosis High-grade Glioma Gliomas
A Prospective Study About the Validity of MRS-guided Resection on Prognosis High-grade Gliomas
NCT02795364CI-TRIAL-00022554unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Gliomas,especially high-grade glioma ,are the most common primary malignant brain tumor in adults,yet outcomes from this aggressive neoplasm remain dismal.The extent of resection is one of the most essential factors that influence the outcomes of glioma resection.However, conventional structural imaging has failed to accurately delineate glioma margins because of tumor cell infiltration. the investigators have finished few project that suggest the feasibility of Magnetic Resonance Spectrum(MRS)-guided resection,unfortunately, lacking sufficient clinical evidence.This prospective cohort study is to provide a clinical evidence for the validity of MRS-guided resection in patients with HGG .
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Oligoastrocytoma | Anaplastic Oligoastrocytoma | CURATED_BROADER | 0.80 |
| Glioblastomas (GBM) | Glioblastoma | ALIAS | 0.85 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metabolic Image Guidance | Procedure | — | UNRESOLVED |
| Structural Image Guidance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Structural Image Guidance
- description
- In this arm, the patients will receive maximum resection of the tumor with the MRI T1W-enhanced image guidance, in addition to the standard therapy
- interventionNames
- Procedure: Structural Image Guidance
- type
- EXPERIMENTAL
- label
- Metabolic Image Guidance
- description
- In this arm, the patients will receive quantitative resection of the tumor with both the MRI T1W-enhanced and the MRS Cho-to-NAA index (CNI) image guidance, in addition to the standard therapy.
- interventionNames
- Procedure: Metabolic Image Guidance
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years \< age ≤ 70 years, both genders. * Post-operative histological pathology confirms HGGs (anaplastic glioma (AG) and Glioblastomas (GBM),2007 World Health Organization(WHO) classification Grade III IV). * No chemotherapy and radiotherapy history * Karnofsky performance score of ≥ 60% * Written informed consent must be obtained from all patients, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: * Tumor involves more than 3 cerebral lobes (gliomatosis or multiple gliomas ). * Tumor is histopathology verified or complicated with other intracranial neoplasms (e.g. metastatic tumors ). * Tumor is complicated with systematic malignancies. * Tumor recurrence or complicated with disease that result in psychological and cognitive problem * Participate in other clinical trials at meantime. * Voluntarily quit .
References
Publications (8)
- BACKGROUNDLe Rhun E, Rhun EL, Taillibert S, Chamberlain MC. The future of high-grade glioma: Where we are and where are we going. Surg Neurol Int. 2015 Feb 13;6(Suppl 1):S9-S44. doi: 10.4103/2152-7806.151331. eCollection 2015. PMID 25722939
- BACKGROUNDMohammadi AM, Hawasli AH, Rodriguez A, Schroeder JL, Laxton AW, Elson P, Tatter SB, Barnett GH, Leuthardt EC. The role of laser interstitial thermal therapy in enhancing progression-free survival of difficult-to-access high-grade gliomas: a multicenter study. Cancer Med. 2014 Aug;3(4):971-9. doi: 10.1002/cam4.266. Epub 2014 May 9. PMID 24810945
- BACKGROUNDLi XZ, Li YB, Cao Y, Li PL, Liang B, Sun JD, Feng ES. Prognostic implications of resection extent for patients with glioblastoma multiforme: a meta-analysis. J Neurosurg Sci. 2017 Dec;61(6):631-639. doi: 10.23736/S0390-5616.16.03619-5. Epub 2016 Jan 29. PMID 26824196
- BACKGROUNDLi YM, Suki D, Hess K, Sawaya R. The influence of maximum safe resection of glioblastoma on survival in 1229 patients: Can we do better than gross-total resection? J Neurosurg. 2016 Apr;124(4):977-88. doi: 10.3171/2015.5.JNS142087. Epub 2015 Oct 23. PMID 26495941
- BACKGROUNDGuo J, Yao C, Chen H, Zhuang D, Tang W, Ren G, Wang Y, Wu J, Huang F, Zhou L. The relationship between Cho/NAA and glioma metabolism: implementation for margin delineation of cerebral gliomas. Acta Neurochir (Wien). 2012 Aug;154(8):1361-70; discussion 1370. doi: 10.1007/s00701-012-1418-x. Epub 2012 Jun 23. PMID 22729482
- BACKGROUNDZhang J, Zhuang DX, Yao CJ, Lin CP, Wang TL, Qin ZY, Wu JS. Metabolic approach for tumor delineation in glioma surgery: 3D MR spectroscopy image-guided resection. J Neurosurg. 2016 Jun;124(6):1585-93. doi: 10.3171/2015.6.JNS142651. Epub 2015 Dec 4. PMID 26636387
- BACKGROUNDZou QG, Xu HB, Liu F, Guo W, Kong XC, Wu Y. In the assessment of supratentorial glioma grade: the combined role of multivoxel proton MR spectroscopy and diffusion tensor imaging. Clin Radiol. 2011 Oct;66(10):953-60. doi: 10.1016/j.crad.2011.05.001. Epub 2011 Jun 12.