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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
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Written informed consent must be obtained from all patients, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

    First Posted
    May 24, 2016
    Last Updated
    June 6, 2016
    Sponsor
    Huashan Hospital
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    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].
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    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
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    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.
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    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.
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    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.
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    PubMed Identifier
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    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.
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