Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas
This study has been completed.
Sponsor:
Dartmouth-Hitchcock Medical Center
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
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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 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 Necrosis Recurrence Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on May 22, 2013