Differentiation of Progression From Treatment Effects in... | NCT03102203

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

NCT03102203

Sponsor

Jinling Hospital, China

Status

Unknown status

Last Update Posted

Apr 5, 2017Actual

Enrollment

350Estimated

Phase

Not provided

Conditions

Glioma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2016Actual

Primary Completion Date

May 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Mar 24, 2017

First Submission Date that Met QC Criteria

Mar 30, 2017

First Posted Date

Apr 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2017

Last Update Posted Date

Apr 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuan Xie, Master	Contact	+86 13584099838		cheryl050914@163.com

Overall Officials

Name	Affiliation	Role
Guang Ming Lu, Doctor	Jinling Hospital, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinling Hospital	Recruiting	Nanjing	Jiangsu	210002	China

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided