Glioblastoma MultiformeNCT02441322
Evaluating Therapeutic Response to Novo-TTF
A study testing Novo-TTF in people with Glioblastoma Multiforme, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Novo-TTF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed or recurrent GBMs
- Received maximal debulking surgery and radiotherapy (protons or photons) concomitant with Temozolomide (40-75Gy)
- Patients may enroll in the study if received Gliadel wafers before entering the trial.
- Minimal dose for concomitant radiotherapy is 40 Gy
- Karnofsky scale of 60 or greater
- Life expectancy at least 3 months
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- Must sign written informed consent
- Treatment start date at least 4 weeks out from surgery or as soon as skin healing/radiation reaction allows
- Measurable enhancing neoplasm on post contrast T1 weighted images and/or non enhancing FLAIR signal abnormality
Who cannot join
- Actively participating in another clinical treatment trial
- Pregnant
- Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
- Thrombocytopenia (platelet count less than 100 x 1000 per microlitre)
- Neutropenia (absolute neutrophil count less than 1.5 x 1000 per microlitre)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
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- Significant liver function impairment AST or ALT 3 times the upper limit of normal
- Total bilirubin upper limit of normal
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: High Resolution MRI and MRS to Evaluate Therapeutic Response to Novo-TTF in Newly and Recurrent Glioblastomas
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.
Read the detailed description
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Novo-TTF
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novo-TTFDevice
Also called Optune
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.
| Study group | Role | What they receive |
|---|---|---|
| Methods to identify treatment response | Experimental | 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. Receives: Device: Novo-TTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological response using standard of care bi monthly MRI scans
MRI scans will be used to help track radiological response to Optune therapy
Measured: up to 2 years
Secondary outcomes (3)
Overall survival (OS)
Evaluating patient overall survival on Optune therapy
Measured: up to 2 years
Progression free survival time
Monitoring patient progression free survival time on Optune therapy
Measured: up to 2 years
Treatment Response using modified RANO criterion
Optune therapy treatment response will be measured using modified RANO criterion
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suyash Mohan, Dr., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441322
- Sponsor's protocol ID
- 12314
- Other IDs
- 820817
- Status last verified
- Jul 2024
- First submitted
- 11 Feb 2015
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution MRI and MRS to Evaluate Therapeutic Response to Novo-TTF in Newly and Recurrent Glioblastomas
- ClinicalTrials.gov ID
- NCT02441322
- Acronym / sponsor ID
- 12314
- Conditions
- Glioblastoma Multiforme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methods to identify treatment response | Experimental | Device: Novo-TTFThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed or recurrent GBMs
- Received maximal debulking surgery and radiotherapy (protons or photons) concomitant with Temozolomide (40-75Gy)
- Patients may enroll in the study if received Gliadel wafers before entering the trial.
- Minimal dose for concomitant radiotherapy is 40 Gy
- Karnofsky scale of 60 or greater
Key exclusion criteria (13 listed)
- Actively participating in another clinical treatment trial
- Pregnant
- Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
- Infra-tentorial tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novo-TTFAlso: OptuneProcedures: 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. | Device | Methods to identify treatment response |
Primary outcome
Radiological response using standard of care bi monthly MRI scans
Time frame: up to 2 years
MRI scans will be used to help track radiological response to Optune therapy
3 secondary outcomes
Overall survival (OS)
Time frame: up to 2 years
Progression free survival time
Time frame: up to 2 years
Treatment Response using modified RANO criterion
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suyash Mohan, Dr. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novo-TTF in people with Glioblastoma Multiforme, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological response using standard of care bi monthly MRI scans (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.