NCT02795364

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

May 24, 2016

Last Update Submit

June 6, 2016

Conditions

GliomaAnaplastic OligoastrocytomaGlioblastomas (GBM)

Keywords

High Grade GliomaMagnetic Resonance SpectroscopySurgical resectionPrognosis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    To determine time to death in the enrolled patients.

    within 1 year after the surgery

Secondary Outcomes (2)

  • Progression free survival (PFS)

    within 1 year after the surgery

  • Karnofsky performance status (KPS)

    3, 6, 9 and 12 months after the surgery

Study Arms (2)

Structural Image Guidance

ACTIVE COMPARATOR

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

Metabolic Image Guidance

EXPERIMENTAL

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

Interventions

Structural Image GuidancePROCEDURE

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

Structural Image Guidance
Metabolic Image GuidancePROCEDURE

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

Metabolic Image Guidance

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 25722939BACKGROUND

  • 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.

    PMID: 24810945BACKGROUND

  • 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.

    PMID: 26824196BACKGROUND

  • 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.

    PMID: 26495941BACKGROUND

  • 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.

    PMID: 22729482BACKGROUND

  • 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.

    PMID: 26636387BACKGROUND

  • 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.

    PMID: 21663899BACKGROUND

  • 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.

    PMID: 24929994BACKGROUND

MeSH Terms

Conditions

GliomaGlioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytoma

Study Officials

  • Jinsong Wu, Professor

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsong Wu, Professor

CONTACT

86 21 52887200wjsongc@126.com

Huashan Hospital Fudan University, Professor

CONTACT

86 21 52887200wjsongc@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 10, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

June 10, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share