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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00942760     History of Changes
Other Study ID Numbers: D0901, DMS-0901
Study First Received: July 20, 2009
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014