Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Clinical Trial With Multimodality MR Imaging

March 30, 2017 updated by: Lu Guang Ming, Nanjing Jinling Hospital

Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Prospective Multicenter Clinical Trial With Multimodality MR Imaging

To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the establishment of new diagnostic criteria for the identification of true and pseudoprogression of high-grade gliomas.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

350

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Jinling Hospital
        • Contact:

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Eligibility module specifies the criteria for determining which people are (or are not) eligible to participate in the study

Description

Inclusion Criteria:

  1. Patients with high-grade gliomas confirmed by pathology and have not been treated with concurrent chemoradiotherapy;
  2. Written informed consent is obtained.

Exclusion Criteria:

  1. Patients not suitable for enhanced MRI scanning of patients;
  2. Patients who have not finished follow-up concurrent chemoradiotherapy or MR scanning.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ktrans
Time Frame: baseline
The volume transfer constant in dynamic contrast-enhanced MR Imaging
baseline
Ktrans
Time Frame: 3 months
The volume transfer constant in dynamic contrast-enhanced MR Imaging
3 months
Ktrans
Time Frame: 10 months
The volume transfer constant in dynamic contrast-enhanced MR Imaging
10 months

Collaborators and Investigators

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

Sponsor

Nanjing Jinling Hospital

Investigators

  • Principal Investigator: Guang Ming Lu, Doctor, Nanjing Jinling Hospital

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 (Actual)

June 8, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanjingJH01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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