Clinical trial · Interventional
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
NCT00747253CI-TRIAL-00053473completedPhase 1ClinicalTrials.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)
The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Neoplasm | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor, Recurrent | Brain Neoplasm | CURATED_BROADER | 0.78 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Recurrent Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AutoLITT system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Active Arm
- description
- Only Arm. Patients treated using AutoLITT System.
- interventionNames
- Device: AutoLITT system
Primary outcomes (1)
- measure
- Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
- timeFrame
- 14 days post-surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy * Clinical/radiographic suspicion of tumor recurrence/progression Exclusion Criteria: * Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
References
Publications (1)
- DERIVEDSloan AE, Ahluwalia MS, Valerio-Pascua J, Manjila S, Torchia MG, Jones SE, Sunshine JL, Phillips M, Griswold MA, Clampitt M, Brewer C, Jochum J, McGraw MV, Diorio D, Ditz G, Barnett GH. Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article. J Neurosurg. 2013 Jun;118(6):1202-19. doi: 10.3171/2013.1.JNS1291. Epub 2013 Apr 5. PMID 23560574