GliomaNCT02941302
Multimodality Imaging Combined With Multiple Targets Pathological Examination for Detecting of Biological Borders of Gliomas: a Clinical Application Study
A study testing Detecting of Biological Borders of Gliomas in people with Glioma, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment planning. In particular, the localization of the border zone between tumor infiltrated and normal brain tissue is one of the major problems to be solved before beginning therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma
- What is being tested?
- Detecting of Biological Borders of Gliomas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed, newly diagnosed intracranial glioma
- A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
- Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative
Who cannot join
- Patient without brain gliomas
- Inability to obtain histological proof of glioma (functional domain and particular domain)
- Psychiatric conditions precluding informed consent
- Patients who cannot tolerate operation
- Patients who are pregnant or breast feeding
- Urine pregnancy test will be performed on women of child bearing potential
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Xia Hechun, M.D., 8613995109559, xhechun@aliyun.com
About this study
Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment planning. In particular, the localization of the border zone between tumor infiltrated and normal brain tissue is one of the major problems to be solved before beginning therapy. However, it is a well known problem that, in conventional magnetic resonance imaging (MRI), it often is difficult to detect areas with low tumor infiltration, especially in gliomas, because of their infiltrative and often diffuse nature.The study has two purpose:I.To correlate the imaging border zone with pathological grade of different tumor site following surgery in patients with newly diagnosed intracranial gliomas, work out the biological border zone, and complete resect the tumor.II.To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging.
Read the detailed description
Gliomas are widely infiltrative tumors. Although an oncological resection is not feasible, there is compelling evidence that patients benefit from resection of the tumor. The surgical target is the main tumor bulk, which is defined as the contrast enhancing part of the tumor on preoperative MRI. Surgical treatment in gliomas is based on maximal safe resection of this mass. Several new technologies have been devised to maximize the resection and intraoperative MRI is one of these new technologies. Intraoperative MRI has been shown by many studies to increase the extent of resection in glioma surgery. Intraoperative determination of the extent of resection, however, requires use of intravenous contrast administration, which has some technical limitations. Fundamental problems associated with the use of contrast material are the enhancement at the resection margin and contrast leakage into the resection cavity. Both problems can complicate the differential diagnosis between residual tumor and surgically induced changes. Nowadays, the basic theory of a largest removal the tumor is the imaging boundary.
Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment planning. In particular, the localization of the border zone between tumor infiltrated and normal brain tissue is one of the major problems to be solved before beginning therapy. However, it is a well known problem that, in conventional magnetic resonance imaging (MRI), it often is difficult to detect areas with low tumor infiltration, especially in gliomas, because of their infiltrative and often diffuse nature.
- Conditions
- Glioma
- Being tested
- Detecting of Biological Borders of Gliomas
- Keywords
- gliomas, biological boundary, imaging border, operation
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detecting of Biological Borders of GliomasProcedure or surgery
Neural navigation combined with Intraoperative ultrasound detecting the borders of gliomas, In accordance with established plan to collect multiple targets undergo pathological examination and contrast with imaging boundary to determine the biological boundaries.
| Study group | Role | What they receive |
|---|---|---|
| determine the biological boundaries | Experimental | Neural navigation combined with Intraoperative ultrasound detecting the borders of gliomas, In accordance with established plan to collect multiple targets undergo pathological examination and contrast with imaging boundary to determine the biological boundaries. Receives: Procedure: Detecting of Biological Borders of Gliomas |
What is being measured
The primary outcome is the main question the study is designed to answer.
the biological border zone of glioma
Neural navigation combined with Intraoperative ultrasound detecting the borders of gliomas, In accordance with established plan to collect multiple targets undergo pathological examination and contrast with imaging boundary to determine the biological boundaries.Pathological specimen collection:Marked by the tumor center, in a clockwise order of the maximum geometric figure of the tumor:1.Front boundary. 2.Right boundary. 3.Rear boundary. 4.Left boundary. 5.Deepest part
Measured: during the operation
Secondary outcomes (1)
the degree of surgical resection of gliomas
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia hechun, M.D., Study chair, General Hospital of Ningxia Medical UniversityWang Xiaodong, M.D., Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941302
- Sponsor's protocol ID
- xhechun3
- Status last verified
- Nov 2017
- First submitted
- 17 Oct 2016
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Imaging Combined With Multiple Targets Pathological Examination for Detecting of Biological Borders of Gliomas: a Clinical Application Study
- ClinicalTrials.gov ID
- NCT02941302
- Acronym / sponsor ID
- xhechun3
- Conditions
- Glioma
- Keywords
- gliomas, biological boundary, imaging border, operation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 21 Oct 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.
Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment planning. In particular, the localization of the border zone between tumor infiltrated and normal brain tissue is one of the major problems to be solved before beginning therapy. However, it is a well known problem that, in conventional magnetic resonance imaging (MRI), it often is difficult to detect areas with low tumor infiltration, especially in gliomas, because of their infiltrative and often diffuse nature.The study has two purpose:I.To correlate the imaging border zone with pathological grade of different tumor site following surgery in patients with newly diagnosed intracranial gliomas, work out the biological border zone, and complete resect the tumor.II.To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging.
Detailed description
Gliomas are widely infiltrative tumors. Although an oncological resection is not feasible, there is compelling evidence that patients benefit from resection of the tumor. The surgical target is the main tumor bulk, which is defined as the contrast enhancing part of the tumor on preoperative MRI. Surgical treatment in gliomas is based on maximal safe resection of this mass. Several new technologies have been devised to maximize the resection and intraoperative MRI is one of these new technologies. Intraoperative MRI has been shown by many studies to increase the extent of resection in glioma surgery. Intraoperative determination of the extent of resection, however, requires use of intravenous contrast administration, which has some technical limitations. Fundamental problems associated with the use of contrast material are the enhancement at the resection margin and contrast leakage into the resection cavity. Both problems can complicate the differential diagnosis between residual tumor and surgically induced changes. Nowadays, the basic theory of a largest removal the tumor is the imaging boundary.
Knowledge of the spatial extent of gliomas is an essential prerequisite for the treatment planning. In particular, the localization of the border zone between tumor infiltrated and normal brain tissue is one of the major problems to be solved before beginning therapy. However, it is a well known problem that, in conventional magnetic resonance imaging (MRI), it often is difficult to detect areas with low tumor infiltration, especially in gliomas, because of their infiltrative and often diffuse nature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| determine the biological boundaries | Experimental | Procedure: Detecting of Biological Borders of GliomasNeural navigation combined with Intraoperative ultrasound detecting the borders of gliomas, In accordance with established plan to collect multiple targets undergo pathological examination and contrast with imaging boundary to determine the biological boundaries. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed, newly diagnosed intracranial glioma
- A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
- Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative
Key exclusion criteria (6 listed)
- Patient without brain gliomas
- Inability to obtain histological proof of glioma (functional domain and particular domain)
- Psychiatric conditions precluding informed consent
- Patients who cannot tolerate operation
- Patients who are pregnant or breast feeding
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 |
|---|---|---|
| Detecting of Biological Borders of GliomasNeural navigation combined with Intraoperative ultrasound detecting the borders of gliomas, In accordance with established plan to collect multiple targets undergo pathological examination and contrast with imaging boundary to determine the biological boundaries. | Procedure or surgery | determine the biological boundaries |
Primary outcome
the biological border zone of glioma
Time frame: during the operation
Neural navigation combined with Intraoperative ultrasound detecting the borders of gliomas, In accordance with established plan to collect multiple targets undergo pathological examination and contrast with imaging boundary to determine the biological boundaries.Pathological specimen collection:Marked by the tumor center, in a clockwise order of the maximum geometric figure of the tumor:1.Front boundary. 2.Right boundary. 3.Rear boundary. 4.Left boundary. 5.Deepest part
1 secondary outcome
the degree of surgical resection of gliomas
Time frame: 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Glioma
Not yet recruitingPhase 1
Immune Modulatory DC Vaccine Against Brain Tumor
Diffuse Intrinsic Pontine Glioma or Glioblastoma
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Not yet recruitingPhase 1
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
Not yet recruitingPhase 1/2
H3K27M-specific Immune Effector Cells Targeting DMG/DIPG
Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma
RecruitingPhase 2
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
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.
Xia hechun, M.D. study chair
General Hospital of Ningxia Medical University
Wang Xiaodong, M.D. principal investigator
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detecting of Biological Borders of Gliomas in people with Glioma, run by General Hospital of Ningxia Medical University at 1 site in China.
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 3 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 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xia hechun, M.D. (8613995109559, xhechun@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the biological border zone of glioma (time frame: during the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2017; AzTrials last refreshed its copy on 1 Nov 2026.