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

NCT02941302 | Unknown DMC

• 1 other identifier: xhechun3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

gliomas; biological boundary; imaging border; operation

Outcome Measures

Primary Outcomes (1)

• 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

  during the operation

Secondary Outcomes (1)

• the degree of surgical resection of gliomas

  24 hours after operation

Other Outcomes (1)

• the optimal target volume for radiation therapy

  3 months after operation

Study Arms (1)

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.

Procedure: Detecting of Biological Borders of Gliomas

Interventions

Detecting of Biological Borders of Gliomas 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.

determine the biological boundaries

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Xia hechun, M.D.

  General Hospital of Ningxia Medical University

  STUDY CHAIR

• Wang Xiaodong, M.D.

  General Hospital of Ningxia Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia hechun, M.D.

CONTACT

8613995109559; xhechun@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)