NCT00942760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 8, 2013

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

July 20, 2009

Last Update Submit

May 7, 2013

Conditions

Recurrent High Grade Gliomas

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T

    24 months

Study Arms (1)

Research MRI

High Grade Glioma patients who show progression based on MRI

Device: 3T MRI

Interventions

3T MRIDEVICE

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

Research MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recurrent GBM patients

You may qualify if:

  • 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.

You may not qualify if:

  • Any patient who requires urgent surgical resection of MRI abnormality would not be eligible
  • Pregnant women are not eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

May 8, 2013

Record last verified: 2012-07

Locations

US(1)