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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Prospective Study About the Validity of MRS-guided Resection on Prognosis High-grade Gliomas

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 Summary:

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 progn
Sponsor: Huashan Hospital

Current Primary Outcome: Overall survival [ Time Frame: within 1 year after the surgery ]

To determine time to death in the enrolled patients.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Huashan Hospital

Dates:
Date Received: May 24, 2016
Date Started: June 2016
Date Completion: May 2018
Last Updated: June 6, 2016
Last Verified: June 2016