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Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942760
First Posted: July 21, 2009
Last Update Posted: May 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate the response to treatment. Sometimes the images obtained are not specific and the only way to establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to determine if multimodal MR technique will provide tissue signatures that differentiate between tumor progression and treatment related necrosis in high grade glioma patients.

Condition Intervention
Recurrent High Grade Gliomas Device: 3T MRI

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • To prospectively acquire multiparameter MR variables at 1.5T and 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and radiation necrosis as established by pathologic examination. [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T [ Time Frame: 24 months ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Research MRI
High Grade Glioma patients who show progression based on MRI
Device: 3T MRI
The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recurrent GBM patients
Criteria

Inclusion Criteria:

  • Histologically proven high grae glioma with central pathology review at DHMC
  • Age 18 equal to or greater than 18 years
  • Karnofsky performance greater or equal to 60%
  • Patients must have received radiation therapy and chemotherapy but should not have received any anti-angiogenesis therapy.

Exclusion Criteria:

  • Any patient who requires urgent surgical resection of MRI abnormality would not be eligible
  • Pregnant women are not eligible
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942760


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00942760     History of Changes
Other Study ID Numbers: D0901
DMS-0901
First Submitted: July 20, 2009
First Posted: July 21, 2009
Last Update Posted: May 8, 2013
Last Verified: July 2012

Additional relevant MeSH terms:
Glioma
Recurrence
Necrosis
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes