Multimodality Imaging Combined With Multiple Targets Pathological Examination for Detecting of Biological Borders of Gliomas: a Clinical Application Study
Primary Purpose
Glioma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Detecting of Biological Borders of Gliomas
Sponsored by
About this trial
This is an interventional treatment trial for Glioma focused on measuring gliomas, biological boundary, imaging border, operation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- General Hospital of Ningxia Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
determine the biological boundaries
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the degree of surgical resection of gliomas
Full Information
NCT ID
NCT02941302
First Posted
October 17, 2016
Last Updated
November 27, 2017
Sponsor
General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02941302
Brief Title
Multimodality Imaging Combined With Multiple Targets Pathological Examination for Detecting of Biological Borders of Gliomas: a Clinical Application Study
Official Title
Multimodality Imaging Combined With Multiple Targets Pathological Examination for Detecting of Biological Borders of Gliomas: a Clinical Application Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
gliomas, biological boundary, imaging border, operation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
determine the biological boundaries
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Detecting of Biological Borders of Gliomas
Intervention Description
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.
Primary Outcome Measure Information:
Title
the biological border zone of glioma
Description
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
Time Frame
during the operation
Secondary Outcome Measure Information:
Title
the degree of surgical resection of gliomas
Time Frame
24 hours after operation
Other Pre-specified Outcome Measures:
Title
the optimal target volume for radiation therapy
Time Frame
3 months after operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xia hechun, M.D.
Phone
8613995109559
Email
xhechun@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia hechun, M.D.
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wang Xiaodong, M.D.
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Hechun, M.D.
Phone
8613995109559
Email
xhechun@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodality Imaging Combined With Multiple Targets Pathological Examination for Detecting of Biological Borders of Gliomas: a Clinical Application Study
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