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

April 5, 2018 updated by: Dongxiao Zhuang, Huashan Hospital

Combination of 11C-MET PET and MRS in the Diagnosis of Glioma.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRS imaging and 11C-MET PET/CT
Each patient underwent both MRS and MET PET before surgery.
Other: tumors are confirmed by surgery and pathology
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of the combination of MRS and 11C-MET PET/CT
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The relationship between 11C-MET PET/CT results and molecular pathogeneses
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Dongxiao Zhuang, Professor, Huashan Hospital, Sudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 29, 2016

First Submitted That Met QC Criteria

December 31, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81171295

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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