NeuroBlate - een nieuwe vorm van LITT - laser interstitial thermal therapy blijkt veilige en succesvolle operatie techniek voor hersentumoren

5 mei 2013: Bron: Journal of Neurosurgery Posted online on April 5, 2013.

NeuroBlate - een nieuwe vorm van LITT - laser interstitial thermal therapy blijkt veilige en succesvolle operatie techniek voor hersentumoren - glioma blastoma. Dit tonen de eerste resultaten uit een fase I studie.

Tien patiënten met een recidief of progressieve vorm van een hersentumor - Glioma Blastoma Multiforme - GBM waarbij een standaard behandeling van bestraling en chemo haddden gefaald en een op moment van de behandeling inoperatief stadium en omvang van Glioma Blastoma Multiforme - GMB hadden, namen deel aan deze fase I studie, die als doel heeft de veiligheid en dosering te testen

De patiënten werden verdeeld in drie groepen bepaald door de hoeveelheid laserenergie (dosis) die gebruikt werd om de tumor te vernietigen met het NeuroBlate systeem. "De mediane overlevingsduur van alle patiënten was 316 dagen Ter vergelijking de mediane overleving die meestal wordt waargenomen voor een recidief van een hersenumor Glioblastoom multiforme bedraagt 90-150 dagen" aldus Dr Gene Barnett, hoogleraar en directeur van het Rose Ella Burkhardt Neuro Oncology Center en vice-voorzitter van de afdeling neurochirurgie van de Cleveland Clinic, waar deze studie werd uitgevoerd

Uiteraard zal verder onderzoek nodig zijn, maar de resultaten zijn bemoedigend en er zullen snel fase II studies worden opgezet met grotere aantallen patiënten. Meer en meer wordt duidelijk dat verfijnde operatie technieken een grote rol kunnen spelen in de levensverlenging van patiënten met vaak inoperabele vormen van kanker. Zoek maar op nanoknife, Myriad, Litt enz. op onze website.

Het volledige studierapport: Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma is gratis in te zien op de website van JNS Neurosurgery. Hier het abstract van de studie:

NeuroBlate represents new technology for delivering laser interstitial thermal therapy, allowing controlled thermal ablation of deep hemispheric recurrent GBM

Source: Journal of Neurosurgery Posted online on April 5, 2013.

ARTICLE

Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma

Clinical article

¹Brain Tumor & Neuro-Oncology Center and Department of Neurosurgery, and ⁹Department of Radiology, University Hospitals Case Medical Center, Seidman Cancer Center; ²Case Comprehensive Cancer Center, and ¹⁰Department of Biomedical Engineering, Case Western Reserve University School of Medicine; ³Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Neurological Institute, Cleveland Clinic; ⁴Department of Solid Tumor Oncology, Taussig Cancer Institute, Cleveland Clinic; ⁵Department of Neurosurgery, Cleveland Clinic; ⁸Department of Neuroradiology, Radiology Institute, Cleveland Clinic, Cleveland, Ohio; ⁶Department of Neurosurgery, Cleveland Clinic Florida, Weston, Florida; and ⁷Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada

Abbreviations used in this paper: DTI-FT = diffusion tensor imaging with fiber tracking; DVT = deep vein thrombosis; D1 = maximum width perpendicular to the laser probe; D2 = widest dimension perpendicular to both D1 and the probe; GBM = glioblastoma multiforme; KPS = Karnofsky Performance Status; LITT = laser interstitial thermal therapy; PE = pulmonary embolism; PTT = percentage of tumor treated; rGBM = recurrent GBM; SRS = stereotactic radiosurgery; V A = volume of nontumor treated at intended dose; V D = dosed volume; V I = intended volume; V T = target volume; V U = undosed volume.

Address correspondence to: Gene H. Barnett, M.D., M.B.A., The Rose Ella Burkhardt Brain Tumor & Neuro-Oncology Center, Cleveland Clinic Neurological and Cancer Institutes, Cleveland Clinic/S73, 9500 Euclid Avenue, Cleveland, Ohio 44195. email: barnetg@ccf.org.

Please include this information when citing this paper: published online April 5, 2013; DOI: 10.3171/2013.1.JNS1291.

By Keywords:: laser interstitial thermal therapy, glioblastoma,coagulation, brain tumor, clinical trial, oncology

Abstract

OBJECT

Laser interstitial thermal therapy has been used as an ablative treatment for glioma; however, its development was limited due to technical issues. The NeuroBlate System incorporates several technological advances to overcome these drawbacks. The authors report a Phase I, thermal dose–escalation trial assessing the safety and efficacy of NeuroBlate in recurrent glioblastoma multiforme (rGBM).

METHODS

Adults with suspected supratentorial rGBM of 15- to 40-mm dimension and a Karnofsky Performance Status score of ≥ 60 were eligible. After confirmatory biopsy, treatment was delivered using a rigid, gas-cooled, side-firing laser probe. Treatment was monitored using real-time MRI thermometry, and proprietary software providing predictive thermal damage feedback was used by the surgeon, along with control of probe rotation and depth, to tailor tissue coagulation. An external data safety monitoring board determined if toxicity at lower levels justified dose escalation.

RESULTS

Ten patients were treated at the Case Comprehensive Cancer Center (Cleveland Clinic and University Hospitals–Case Medical Center). Their average age was 55 years (range 34–69 years) and the median preoperative Karnofsky Performance Status score was 80 (range 70–90). The mean tumor volume was 6.8 ± 5 cm³ (range 2.6–19 cm³), the percentage of tumor treated was 78% ± 12% (range 57%–90%), and the conformality index was 1.21 ± 0.33 (range 1.00–2.04). Treatment-related necrosis was evident on MRI studies at 24 and 48 hours. The median survival was 316 days (range 62–767 days). Three patients improved neurologically, 6 remained stable, and 1 worsened. Steroid-responsive treatment-related edema occurred in all patients but one. Three had Grade 3 adverse events at the highest dose.

CONCLUSIONS

NeuroBlate represents new technology for delivering laser interstitial thermal therapy, allowing controlled thermal ablation of deep hemispheric rGBM. Clinical trial registration no.: NCT00747253 (ClinicalTrials.gov).

immuuntherapie, dendritische celtherapie, complementair, Myriad, NeuroBlat, glioma blastoma multiforma, hersentumoren