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Study About the Validity of MRS-guided Resection on Prognosis High-grade Glioma Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02795364
Recruitment Status : Unknown
Verified June 2016 by Jinsong Wu, Huashan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital

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 .

Condition or disease Intervention/treatment Phase
Glioma Anaplastic Oligoastrocytoma Glioblastomas (GBM) Procedure: Structural Image Guidance Procedure: Metabolic Image Guidance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study About the Validity of MRS-guided Resection on Prognosis High-grade Gliomas
Study Start Date : June 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Active Comparator: Structural Image Guidance
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
Procedure: Structural Image Guidance
Resecting the tumor in accordance with the margin on MRI T1W-enhanced delineation

Experimental: Metabolic Image Guidance
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.
Procedure: Metabolic Image Guidance
Aggressive resecting of the tumor in accordance with the margin on MRS CNI delineation

Primary Outcome Measures :
  1. Overall survival [ Time Frame: within 1 year after the surgery ]
    To determine time to death in the enrolled patients.

Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: within 1 year after the surgery ]
    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

  2. Karnofsky performance status (KPS) [ Time Frame: 3, 6, 9 and 12 months after the surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02795364

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Contact: Jinsong Wu, Professor 86 21 52887200
Contact: Huashan Hospital Fudan University, Professor 86 21 52887200

Sponsors and Collaborators
Huashan Hospital
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Principal Investigator: Jinsong Wu, Professor Huashan Hospital

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Responsible Party: Jinsong Wu, Professor, Huashan Hospital Identifier: NCT02795364    
Other Study ID Numbers: KY2016-232
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Jinsong Wu, Huashan Hospital:
High Grade Glioma
Magnetic Resonance Spectroscopy
Surgical resection
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue