GliomaNCT02795364
Study About the Validity of MRS-guided Resection on Prognosis High-grade Glioma Gliomas
A study testing Structural Image Guidance and Metabolic Image Guidance in people with Glioma and Anaplastic Oligoastrocytoma, run by Huashan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Anaplastic Oligoastrocytoma, Glioblastomas (GBM)
- What is being tested?
- Structural Image Guidance and Metabolic Image Guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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- Written informed consent must be obtained from all patients, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Study About the Validity of MRS-guided Resection on Prognosis High-grade Gliomas
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 .
Read the 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.
- Conditions
- Glioma, Anaplastic Oligoastrocytoma, Glioblastomas (GBM)
- Being tested
- Structural Image Guidance, Metabolic Image Guidance
- Keywords
- High Grade Glioma, Magnetic Resonance Spectroscopy, Surgical resection, Prognosis
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural Image GuidanceProcedure or surgery
Resecting the tumor in accordance with the margin on MRI T1W-enhanced delineation
Metabolic Image GuidanceProcedure or surgery
Aggressive resecting of the tumor in accordance with the margin on MRS CNI delineation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Metabolic Image Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To determine time to death in the enrolled patients.
Measured: within 1 year after the surgery
Secondary outcomes (2)
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
Measured: within 1 year after the surgery
Karnofsky performance status (KPS)
Measured: 3, 6, 9 and 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Jinsong Wu, Professor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795364
- Sponsor's protocol ID
- KY2016-232
- Status last verified
- Jun 2016
- First submitted
- 24 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 25722939Mohammadi 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.
PubMed 24810945Li 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.
PubMed 26824196Li 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.
PubMed 26495941Guo 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.
PubMed 22729482Zhang 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.
PubMed 26636387Zou 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.
PubMed 21663899Aibaidula 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.
PubMed 24929994
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study About the Validity of MRS-guided Resection on Prognosis High-grade Gliomas
- ClinicalTrials.gov ID
- NCT02795364
- Acronym / sponsor ID
- KY2016-232
- Conditions
- Glioma, Anaplastic Oligoastrocytoma, Glioblastomas (GBM)
- Keywords
- High Grade Glioma, Magnetic Resonance Spectroscopy, Surgical resection, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structural Image Guidance | Active comparator | Procedure: Structural Image GuidanceIn this arm, the patients will receive maximum resection of the tumor with the MRI T1W-enhanced image guidance, in addition to the standard therapy |
| Metabolic Image Guidance | Experimental | Procedure: Metabolic Image GuidanceIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural Image GuidanceResecting the tumor in accordance with the margin on MRI T1W-enhanced delineation | Procedure or surgery | Structural Image Guidance |
| Metabolic Image GuidanceAggressive resecting of the tumor in accordance with the margin on MRS CNI delineation | Procedure or surgery | Metabolic Image Guidance |
Primary outcome
Overall survival
Time frame: within 1 year after the surgery
To determine time to death in the enrolled patients.
2 secondary outcomes
Progression free survival (PFS)
Time frame: within 1 year after the surgery
Karnofsky performance status (KPS)
Time frame: 3, 6, 9 and 12 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Background: PubMed 25722939Le 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.
- Background: PubMed 24810945Mohammadi 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.
- Background: PubMed 26824196Li 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.
- Background: PubMed 26495941Li 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.
- Background: PubMed 22729482Guo 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.
- Background: PubMed 26636387Zhang 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.
- Background: PubMed 21663899Zou 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.
- Background: PubMed 24929994Aibaidula 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsong Wu, Professor principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Structural Image Guidance and Metabolic Image Guidance in people with Glioma and Anaplastic Oligoastrocytoma, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Wu, Professor (86 21 52887200, wjsongc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: within 1 year after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795364, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.