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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00589095
• Other study ID #: 0606001531
• Status: Terminated
• Phase: N/A
• First received: January 2, 2008
• Last updated: July 1, 2014
• Start date: November 2006
• Est. completion date: August 2011

Study information

• Verified date: July 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Other:
• dynamic contrast enhanced magnetic resonance imaging
dynamic contrast enhanced MRI using contrast agent gadodiamide

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV)		Upon completion of study	No