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NCT03102203 Clinical Trial

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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03102203
Other study ID # NanjingJH01
Secondary ID
Status Recruiting
Phase N/A
First received March 24, 2017
Last updated March 30, 2017
Start date June 8, 2016
Est. completion date December 2018

Study information
Verified date March 2017
Source Nanjing Jinling Hospital
Contact Yuan Xie, Master
Phone +86 13584099838
Email cheryl050914@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date December 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Jinling Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Nanjing Jinling Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ktrans The volume transfer constant in dynamic contrast-enhanced MR Imaging baseline
Primary Ktrans The volume transfer constant in dynamic contrast-enhanced MR Imaging 3 months
Primary Ktrans The volume transfer constant in dynamic contrast-enhanced MR Imaging 10 months
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