Clinical trial NCT02941302: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: gliomas
biological boundary
imaging border
operation
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the biological border zone of glioma
timeFrame: during the operation
Secondary outcomes:
measure: the degree of surgical resection of gliomas
timeFrame: 24 hours after operation
Other outcomes:
measure: the optimal target volume for radiation therapy
timeFrame: 3 months after operation
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Xia hechun, M.D.
role: STUDY_CHAIR
affiliation: General Hospital of Ningxia Medical University
name: Wang Xiaodong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: