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Multimodality Imaging Combined With Multiple Targets Pathological Examination for Detecting of Biological Borders of Gliomas: a Clinical Application Study

NCT ID: NCT02941302

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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

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Glioma

Keywords

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gliomas biological boundary imaging border operation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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determine the biological boundaries

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.

Group Type EXPERIMENTAL

Detecting of Biological Borders of Gliomas

Intervention Type PROCEDURE

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.

Interventions

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Detecting of Biological Borders of Gliomas

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

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xia hechun, M.D.

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Wang Xiaodong, M.D.

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Ningxia Medical University

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xia hechun, M.D.

Role: CONTACT

Phone: 8613995109559

Email: [email protected]

Facility Contacts

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Xia Hechun, M.D.

Role: primary

Other Identifiers

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xhechun3

Identifier Type: -

Identifier Source: org_study_id