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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 20, 2009
Last Updated Date	May 7, 2013
Start Date ^ICMJE	April 2009
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 25, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: July 20, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00942760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 25, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: July 20, 2009)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
Official Title ^ICMJE	DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Recurrent GBM patients
Condition ^ICMJE	Recurrent High Grade Gliomas
Intervention ^ICMJE	Device: 3T MRI The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.
Study Group/Cohort (s)	Research MRI High Grade Glioma patients who show progression based on MRI Intervention: Device: 3T MRI
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	April 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00942760
Other Study ID Numbers ^ICMJE	D0901, DMS-0901
Has Data Monitoring Committee	Yes
Responsible Party	Dartmouth-Hitchcock Medical Center
Study Sponsor ^ICMJE	Dartmouth-Hitchcock Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dartmouth-Hitchcock Medical Center
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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