Study About the Validity of MRS-guided Resection on Prognosis High-grade Glioma Gliomas
Primary Purpose
Glioma, Anaplastic Oligoastrocytoma, Glioblastomas (GBM)
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structural Image Guidance
Metabolic Image Guidance
Sponsored by
About this trial
This is an interventional treatment trial for Glioma focused on measuring High Grade Glioma, Magnetic Resonance Spectroscopy, Surgical resection, Prognosis
Eligibility Criteria
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- Written informed consent must be obtained from all patients, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Structural Image Guidance
Metabolic Image Guidance
Arm 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
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.
Outcomes
Primary Outcome Measures
Overall survival
To determine time to death in the enrolled patients.
Secondary Outcome Measures
Progression free survival (PFS)
The survival rate of followed patients without progressive disease (PD) 3, 6, 9, and 12 months after the operation,To determine time to tumor progression in this The survival rate of followed patients without progressive disease (PD) 3,6, 9,and 12 months after the operation,To determine time to tumor progression in this patient population
Karnofsky performance status (KPS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02795364
Brief Title
Study About the Validity of MRS-guided Resection on Prognosis High-grade Glioma Gliomas
Official Title
A Prospective Study About the Validity of MRS-guided Resection on Prognosis High-grade Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 .
Detailed Description
High-grade glioma(HGG), including anaplastic glioma (AG) and Glioblastomas (GBM), are associated with poor prognosis, even with all the scientific development of the last decades, attributed to optimally treated with maximum safe surgery, followed by radiotherapy (RT) and/or systemic chemotherapy (CT). Despite recent advances in treatment, the prognosis of HGG remains poor with comparatively short overall survival (OS) and importantly profound impact on quality of life (QoL).Admittedly,multiple factors are related to their outcome, including age, biological characteristics of the tumor, and extent of treatment. Notably, extent of resection (EOR) plays a major role as an independent modifiable factor associated with improved overall and progression-free survival. Achievement of maximal safe resection, removing as much as possible the tumor while preserving the neurological function, is the main goal of the current surgical treatment of High-grade glioma (HGG).
Many researchers took into study about the extent of surgery ,despite exist various editions,produced similar results, although only one randomized controlled trial(RCT) provided 1-year PFS data and there was no significant difference between total resection and incomplete resection in that study. It suggests that should push the delineation of tumour outward for better prognosis.therefore,the core of conservation point to the simon-pure margins that proximate to histopathologic periphery of HGG.Consequently, analyses showed that the resection of ≥ 53.21% of the surrounding FLAIR abnormality beyond the 100% contrast-enhancing resection was associated with a significant prolongation of survival compared with that following less extensive resections,neo-FLAIR abnormality region is gradually coming into people' vision,supportive evidence is warranted for the relationship of extensive resection and reasonable prognosis,which equal to draw the scope of tumour margins that has been put forward to sketch via metabolic information.
During previous clinical practice,the investigators have researched that the correlation of metabolic information and tumour identification about true-false type,study suggests that Cho/tNAA ratio threshold values of 0.5, 1.0, 1.5 and 2.0 appeared to predict the specie-mens containing the tumour with respective probabilities of 0.38, 0.60, 0.79, 0.90 in HGG and 0.16, 0.39, 0.67, 0.87 in LGG,it is interesting to reveal the metabolic action of true-tumour,and immediately the other work projected by our group found that the differences between the structural and the metabolic volumes with Cho/tNAA ratio(CNI) thresholds of 0.5 and 1.5 were statistically significant (p = 0.0005 and 0.0129, respectively) and 0.5 and 1.0 were statistically significant in HGG.Problem,whether operation that resect by delineation at Cho/tNAA ratio threshold 1.0 can bring better outcome ,remains to be solved,namely,the investigators need further clinical evidence .
Based on this thoughtfulness, this prospective cohort study is to provide a reasonable evidence for the correlation between metabolic-guide resection and the prognosis of the HGGs , cohorts contain 25 cases in the arm group and 25 cases in the control group.Respectively receive different operation project followed by statistical analysis aim at overall survival (OS)and progression free survival (PFS).Definitively,the investigators hope to draw a conclusion that armed group has better outcome,like that,studies have a step in the course of HGG therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Anaplastic Oligoastrocytoma, Glioblastomas (GBM)
Keywords
High Grade Glioma, Magnetic Resonance Spectroscopy, Surgical resection, Prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Structural Image Guidance
Arm Type
Active Comparator
Arm 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
Arm Title
Metabolic Image Guidance
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Structural Image Guidance
Intervention Description
Resecting the tumor in accordance with the margin on MRI T1W-enhanced delineation
Intervention Type
Procedure
Intervention Name(s)
Metabolic Image Guidance
Intervention Description
Aggressive resecting of the tumor in accordance with the margin on MRS CNI delineation
Primary Outcome Measure Information:
Title
Overall survival
Description
To determine time to death in the enrolled patients.
Time Frame
within 1 year after the surgery
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
The survival rate of followed patients without progressive disease (PD) 3, 6, 9, and 12 months after the operation,To determine time to tumor progression in this The survival rate of followed patients without progressive disease (PD) 3,6, 9,and 12 months after the operation,To determine time to tumor progression in this patient population
Time Frame
within 1 year after the surgery
Title
Karnofsky performance status (KPS)
Time Frame
3, 6, 9 and 12 months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsong Wu, Professor
Phone
86 21 52887200
Email
wjsongc@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huashan Hospital Fudan University, Professor
Phone
86 21 52887200
Email
wjsongc@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsong Wu, Professor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
25722939
Citation
Le 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. Erratum In: Surg Neurol Int. 2015 Mar 05;6:37. Rhun, Emilie Le [corrected to Le Rhun, Emilie].
Results Reference
background
PubMed Identifier
24810945
Citation
Mohammadi 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.
Results Reference
background
PubMed Identifier
26824196
Citation
Li 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.
Results Reference
background
PubMed Identifier
26495941
Citation
Li 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.
Results Reference
background
PubMed Identifier
22729482
Citation
Guo 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.
Results Reference
background
PubMed Identifier
26636387
Citation
Zhang 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.
Results Reference
background
PubMed Identifier
21663899
Citation
Zou 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.
Results Reference
background
PubMed Identifier
24929994
Citation
Aibaidula A, Lu JF, Wu JS, Zou HJ, Chen H, Wang YQ, Qin ZY, Yao Y, Gong Y, Che XM, Zhong P, Li SQ, Bao WM, Mao Y, Zhou LF. Establishment and maintenance of a standardized glioma tissue bank: Huashan experience. Cell Tissue Bank. 2015 Jun;16(2):271-81. doi: 10.1007/s10561-014-9459-4. Epub 2014 Jun 15.
Results Reference
background
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Study About the Validity of MRS-guided Resection on Prognosis High-grade Glioma Gliomas
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