NCT00589095

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.

Trial Health

57
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Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

4.8 years

First QC Date

January 2, 2008

Last Update Submit

July 1, 2014

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV)

    Upon completion of study

Study Arms (1)

1

Other: dynamic contrast enhanced magnetic resonance imaging

Interventions

dynamic contrast enhanced magnetic resonance imagingOTHER

dynamic contrast enhanced MRI using contrast agent gadodiamide

Also known as: Omniscan
1

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

gadodiamide

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jonathan Knisely, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 9, 2008

Study Start

November 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

US(1)