An interventional study of Novo-TTF in Glioblastoma Multiforme, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Health services research
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.
The patient is being asked to have 4 MRI scans of their brain over the course of 6 months. 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 scans will be ordered by the principal investigator of the study and this will include standard MR imaging sequences along with advanced MR spectroscopy (MRS) to help identify response to Optune therapy. Please note: the only portion of the MRI scan that will be research-related are the MRS sequences. The other portion of the imaging will be considered as a standard of care MRI scan that will be reviewed by an attending physician, who will generate an MRI report in the electronic medical record system (EMS). The data collected from the advanced MRS sequences will be reviewed by the principal investigator and will be billed to the research study (you will be billed for the clinical MRI scan as a part of your standard of care).
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 30 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
The investigators will study how well these advanced MRI methods are in accurately identifying response to Novo-TTF in comparison to standard MRI methods for evaluation of treatment response. Using advanced MRI imaging techniques may help assess treatment response earlier than changes in tumor volume which can be measured with standard MRI methods.
Device: Novo-TTF
Procedures: MRI and advanced MRI sequence Advanced brain MRI's with special sequences will be obtained. First MRI prior to starting Novo-TTF therapy, second MRI up to 2-3 weeks after beginning therapy, third MRI up to 2 months from starting treatment and the last MRI up to 4 months after starting treatment.
Also known as: Optune
Radiological response using standard of care bi monthly MRI scans
MRI scans will be used to help track radiological response to Optune therapy
Time frame: up to 2 years
Overall survival (OS)
Evaluating patient overall survival on Optune therapy
Time frame: up to 2 years
Progression free survival time
Monitoring patient progression free survival time on Optune therapy
Time frame: up to 2 years
Treatment Response using modified RANO criterion
Optune therapy treatment response will be measured using modified RANO criterion
Time frame: up to 2 years
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine