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

Recurrent High Grade Gliomas Clinical Trial

Official title:

DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942760
• Other study ID #: D0901
• Secondary ID: DMS-0901
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: May 7, 2013
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Glioma
• Recurrent High Grade Gliomas

Intervention

Device:
• 3T MRI
The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 months	No
Secondary	To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T		24 months	No