Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
10

Summary

Conditions
Glioblastoma Multiforme
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The patient is being asked to have 4 MRI scans of their brain over the course of 6 months. Before the patient can participate in the study a negative urine pregnancy test may be required for women of child-bearing age. Each MRI scan will take approximately 1 hour to complete. The first MRI scan will...

The patient is being asked to have 4 MRI scans of their brain over the course of 6 months. Before the patient can participate in the study a negative urine pregnancy test may be required for women of child-bearing age. Each MRI scan will take approximately 1 hour to complete. The first MRI scan will be performed once the patient is enrolled in the Novo-TTF treatment therapy, but prior to the initiation of Novo-TTF therapy. The second MRI scan will be performed up to 2-3 weeks after therapy had begun. The third MRI scan will be performed up to 2 months from the start of Novo-TTF treatment and the last MRI scan will be performed up to 4 months from the start of Novo-TTF treatment. The MRI study will be conducted at the Center for Advanced Magnetic Resonance Imaging and Spectroscopy in the Department of Radiology, University of Pennsylvania Medical Center. The study scans will be very similar to routine clinical MRI scans of the brain. The patient will be asked to lie on a specially designed bed and a circular antenna will be placed around the patients head. The patient will be given earplugs to wear to decrease the banging noise caused by the imaging process. The earplugs do not block out all sound since the MRI tech's wish to stay in communication with the patient at all times. The MRI techs will then move the patient into the magnet, a large hollow cylinder, until the patients head is at the center. The study will then proceed. The MRI operator will inform the patient of the progress of the study. The patient will need to keep perfectly still during the scanning. During each MRI scan, the patient will have an intravenous line (IV line) placed. The IV line allows the contrast agent to be injected into the patient's vein. MRI contrast agents are chemicals that travel through the bloodstream. They act like dyes to make MRI pictures brighter and easier to read. When the study is complete, the patient will be moved out of the magnet. The MRI operator will ask that the patient please get up slowly since the patient has been lying still for a relatively long period of time. The investigators will also review the patient's medical records for information about medical history, current and past medications and therapies, and other information related to the patient's GBM.

Tracking Information

NCT #
NCT02441322
Collaborators
Not Provided
Investigators
Principal Investigator: Suyash Mohan, Dr. University of Pennsylvania