Clinical trial · Interventional
Feasibility Study on LITT for Newly Diagnosed Glioblastoma
Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
NCT02880410CI-TRIAL-00076019FLAGterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated (failure to enroll)
Summary
Brief summary (as posted)
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).
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 | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NeuroBlate System | Device | — | UNRESOLVED |
| Radiation therapy and temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LITT Treatment w/radiation therapy and temozolomide
- description
- This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide
- interventionNames
- Device: NeuroBlate System
- Drug: Radiation therapy and temozolomide
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 2 Years
- description
- Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
Secondary outcomes (3)
- measure
- Progression-Free Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Relevant Inclusion Criteria: 1. Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy 2. Single enhancing lesion that is \>1 cm, but \< 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm) 3. The patient must be ≥18 years of age 4. KPS \> 70 5. Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years. 6. Stable cardiovascular, pulmonary health status Relevant Exclusion Criteria: 1. Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs 2. Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant 3. Uncontrolled cardiovascular conditions of hypertension (systolic \>180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage 4. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements 5. Pregnancy, or planning to become pregnant 6. Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects 7. Patients with multiple or multifocal GBM
References
Publications (0)
Data not yet available
No reference posted for this study.