Philadelphia, Pennsylvania 19104


Purpose:

This study is to assess the utility of high resolution 3D echo planar magnetic resonance spectroscopy (3D EPSI) in monitoring Novo-TTF response in glioblastoma multiforme (GBM) patients.


Study summary:

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.


Criteria:

Inclusion Criteria: - Newly diagnosed or recurrent GBMs - Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-75Gy) - Patients may enroll in the study if received Gliadel wafers before entering the trial. - Minimal dose for concomitant radiotherapy is 45 Gy - Karnofsky scale of 60 or greater - Life expectancy at least 3 months - Must sign written informed consent - Treatment start date at least 4 weeks out from surgery - Measurable enhancing neoplasm on post contrast T1 weighted images and/or non enhancing FLAIR signal abnormality Exclusion Criteria: - Actively participating in another clinical treatment trial - Pregnant - Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment: 1. Thrombocytopenia (platelet count less than 100 x 1000 per microlitre) 2. Neutropenia (absolute neutrophil count less than 1.5 x 1000 per microlitre) 3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting) 4. Significant liver function impairment AST or ALT 3 times the upper limit of normal 5. Total bilirubin upper limit of normal 6. Significant renal impairment (serum creatinine greater than 1.7 mg/dL) - Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias - Infra-tentorial tumor - Evidence of increased intracranial pressure (midline shift 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) - History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.


NCT ID:

NCT02441322


Primary Contact:

Principal Investigator
Suyash Mohan, Dr.
University of Pennsylvania

Lauren Karpf
Phone: 215-662-7274
Email: lauren.karpf@uphs.upenn.edu


Backup Contact:

Email: lisa.desiderio@uphs.upenn.edu
Lisa Desiderio
Phone: 215-746-7632


Location Contact:

Philadelphia, Pennsylvania 19104
United States

Lauren Karpf
Phone: 215-662-7274
Email: lauren.karpf@uphs.upenn.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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