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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:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00942760
First received: July 20, 2009
Last updated: May 7, 2013
Last verified: July 2012

July 20, 2009
May 7, 2013
April 2009
March 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
To prospectively acquire mutiparametric 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00942760 on ClinicalTrials.gov Archive Site
To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To compare the predictive values of the multiparametric MR tissue signatures acquired at 1.5T and 3T [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Recurrent GBM patients

Recurrent High Grade Gliomas
Device: 3T MRI
The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.
Research MRI
High Grade Glioma patients who show progression based on MRI
Intervention: Device: 3T MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00942760
D0901, DMS-0901
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Not Provided
Not Provided
Dartmouth-Hitchcock Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP