Early Detection of Glioblastoma Multiforme (GBM) Treatmen... | NCT00589095

Studies
Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities

NCT00589095

Sponsor

Yale University

Status

Terminated

Last Update Posted

Jul 2, 2014Estimated

Enrollment

5Estimated

Phase

Not provided

Conditions

Glioblastoma Multiforme

Interventions

dynamic contrast enhanced magnetic resonance imaging

Countries

United States

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jan 2, 2008

First Submission Date that Met QC Criteria

Jan 8, 2008

First Posted Date

Jan 9, 2008Estimated

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

Jul 1, 2014

Last Update Posted Date

Jul 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and high diffusion weighting MRI may be used to distinguish between favorable and unfavorable responses to therapy of glioblastoma multiforme. Imaging data will be correlated with histopathologic findings and clinical responses to radiation therapy with or without chemotherapy.

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

Not provided

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

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1			Other: dynamic contrast enhanced magnetic resonance imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dynamic contrast enhanced magnetic resonance imaging	Other	dynamic contrast enhanced MRI using contrast agent gadodiamide	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV)		Upon completion of study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The presence of a primary brain tumor that cannot be completely resected that requires radiation therapy with or without chemotherapy.

Exclusion Criteria:

Patients who do not have a primary brain tumor or who are unable to tolerate the environment of the MRI scanner

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

Patients referred to the Yale Brain Tumor Center for management of glioblastome multiforme

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan Knisely, M.D.	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale University School of Medicine		New Haven	Connecticut	06520	United States

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C064925	gadodiamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided