Clinical trial · Interventional
Evaluating Therapeutic Response to Novo-TTF
High Resolution MRI and MRS to Evaluate Therapeutic Response to Novo-TTF in Newly and Recurrent Glioblastomas
NCT02441322CI-TRIAL-00078947completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novo-TTF | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Methods to identify treatment response
- description
- 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.
- interventionNames
- Device: Novo-TTF
Primary outcomes (1)
- measure
- Radiological response using standard of care bi monthly MRI scans
- timeFrame
- up to 2 years
- description
- MRI scans will be used to help track radiological response to Optune therapy
Secondary outcomes (3)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.