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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Yale University. Recruitment status was Recruiting

First Received on January 2, 2008. Last Updated on March 9, 2009 History of Changes

Sponsor:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00589095

Purpose

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.

Condition	Intervention
Glioblastoma Multiforme	Other: dynamic contrast enhanced magnetic resonance imaging

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans

Drug Information available for: Gadodiamide

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV) [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	5
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Other: dynamic contrast enhanced magnetic resonance imaging dynamic contrast enhanced MRI using contrast agent gadodiamide Other Name: Omniscan

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589095

Contacts

Contact: Jonathan Knisely, MD

203-785-6128

jonathan.knisely@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Jonathan Knisely, M.D.

Yale University

More Information

No publications provided

Responsible Party:	Jonathan Knisely, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier:	NCT00589095 History of Changes
Other Study ID Numbers:	0606001531
Study First Received:	January 2, 2008
Last Updated:	March 9, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on February 09, 2012