Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Information provided by (Responsible Party):
Yale University Identifier:
First received: January 2, 2008
Last updated: July 1, 2014
Last verified: July 2014

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:

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
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00589095

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Principal Investigator: Jonathan Knisely, M.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University Identifier: NCT00589095     History of Changes
Other Study ID Numbers: 0606001531
Study First Received: January 2, 2008
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors processed this record on February 26, 2015