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MRS and 11C-methionine PET/CT in the Diagnosis of Glioma

Primary Purpose

Glioma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tumors are confirmed by surgery and pathology
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring Glioma, Magnetic resonance spectroscopy, Methionine, PET/CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with non-enhancing supratentorial lesions shown by contrast-enhanced MRI
  2. No surgery, chemotherapy or radiotherapy history
  3. All patients gave written informed consent.

Exclusion Criteria:

  1. Patients with infratentorial Neoplasms
  2. Patients with enhancing supratentorial lesions
  3. Recurrent gliomas after surgery
  4. Primary gliomas with history of radiotherapy or chemotherapy
  5. History of malignant tumours at any body site
  6. Inability to give informed consent

Sites / Locations

  • Huashan hospital, Fudan university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRS imaging and 11C-MET PET/CT

Arm Description

Each patient underwent both MRS and MET PET before surgery.

Outcomes

Primary Outcome Measures

Sensitivity of the combination of MRS and 11C-MET PET/CT

Secondary Outcome Measures

The relationship between 11C-MET PET/CT results and molecular pathogeneses

Full Information

First Posted
December 29, 2016
Last Updated
April 5, 2018
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03009318
Brief Title
MRS and 11C-methionine PET/CT in the Diagnosis of Glioma
Official Title
Combination of 11C-MET PET and MRS in the Diagnosis of Glioma.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
MET PET and MRS are often performed as imaging tool for the differential diagnosis of gliomas. But both techniques have limitations causing misdiagnosis; thus, the investigators tried to combine these two imaging tools to study whether the combination of MET PET and MRS could raise the diagnosis ability of the radiological diagnosis of gliomas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
Glioma, Magnetic resonance spectroscopy, Methionine, PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRS imaging and 11C-MET PET/CT
Arm Type
Other
Arm Description
Each patient underwent both MRS and MET PET before surgery.
Intervention Type
Other
Intervention Name(s)
tumors are confirmed by surgery and pathology
Intervention Description
Each patient undergoes both MRS and MET PET scan before surgery. The lesion will be considered as a glioma when either MRS or MET PET results indicated the diagnosis. Pathologic diagnosis will be performed to confirm the final diagnosis.
Primary Outcome Measure Information:
Title
Sensitivity of the combination of MRS and 11C-MET PET/CT
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The relationship between 11C-MET PET/CT results and molecular pathogeneses
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with non-enhancing supratentorial lesions shown by contrast-enhanced MRI No surgery, chemotherapy or radiotherapy history All patients gave written informed consent. Exclusion Criteria: Patients with infratentorial Neoplasms Patients with enhancing supratentorial lesions Recurrent gliomas after surgery Primary gliomas with history of radiotherapy or chemotherapy History of malignant tumours at any body site Inability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongxiao Zhuang, Professor
Organizational Affiliation
Huashan Hospital, Sudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan hospital, Fudan university
City
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

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MRS and 11C-methionine PET/CT in the Diagnosis of Glioma

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