NCT03102203

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

March 24, 2017

Last Update Submit

March 30, 2017

Conditions

Glioma

Outcome Measures

Primary Outcomes (3)

  • Ktrans

    The volume transfer constant in dynamic contrast-enhanced MR Imaging

    baseline

  • Ktrans

    The volume transfer constant in dynamic contrast-enhanced MR Imaging

    3 months

  • Ktrans

    The volume transfer constant in dynamic contrast-enhanced MR Imaging

    10 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Guang Ming Lu, Doctor

    Jinling Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Xie, Master

CONTACT

+86 13584099838cheryl050914@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 5, 2017

Study Start

June 8, 2016

Primary Completion

May 1, 2018

Study Completion

December 1, 2018

Last Updated

April 5, 2017

Record last verified: 2017-03

Locations

CN(1)