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

Study Purpose

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 .

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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of ≥ 60% - Written informed consent must be obtained from all patients, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 .

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02795364
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Huashan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jinsong Wu, Professor
Principal Investigator Affiliation Huashan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma, Anaplastic Oligoastrocytoma, Glioblastomas (GBM)
Additional Details

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.

Arms & Interventions

Arms

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

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.

Interventions

Procedure: - Structural Image Guidance

Resecting the tumor in accordance with the margin on MRI T1W-enhanced delineation

Procedure: - Metabolic Image Guidance

Aggressive resecting of the tumor in accordance with the margin on MRS CNI delineation

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Jinsong Wu, Professor

[email protected]

86 21 52887200

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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