title: NovoTTF™-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ system user study.
abstract: BACKGROUND
  Optune™, previously known as the NovoTTF-100A System™, generates Tumor Treating Fields (TTFields), an effective anti-mitotic therapy for glioblastoma. The system delivers intermediate frequency, alternating electric fields to the supratentorial brain. Patient therapy is personalized by configuring transducer array layout placement on the scalp to the tumor site using MRI measurements and the NovoTAL System. Transducer array layout mapping optimizes therapy by maximizing electric field intensity to the tumor site. This study evaluated physician performance in conducting transducer array layout mapping using the NovoTAL System compared with mapping performed by the Novocure in-house clinical team.
  
  
  METHODS
  Fourteen physicians (7 neuro-oncologists, 4 medical oncologists, and 3 neurosurgeons) evaluated five blinded cases of recurrent glioblastoma and performed head size and tumor location measurements using a standard Digital Imaging and Communications in Medicine reader. Concordance with Novocure measurement and intra- and inter-rater reliability were assessed using relevant correlation coefficients. The study criterion for success was a concordance correlation coefficient (CCC) >0.80.
  
  
  RESULTS
  CCC for each physician versus Novocure on 20 MRI measurements was 0.96 (standard deviation, SD ± 0.03, range 0.90-1.00), indicating very high agreement between the two groups. Intra- and inter-rater reliability correlation coefficients were similarly high: 0.83 (SD ±0.15, range 0.54-1.00) and 0.80 (SD ±0.18, range 0.48-1.00), respectively.
  
  
  CONCLUSIONS
  This user study demonstrated an excellent level of concordance between prescribing physicians and Novocure in-house clinical teams in performing transducer array layout planning. Intra-rater reliability was very high, indicating reproducible performance. Physicians prescribing TTFields, when trained on the NovoTAL System, can independently perform transducer array layout mapping required for the initiation and maintenance of patients on TTFields therapy.
authors.affiliation: Medical Affairs, Novocure Ltd., New York, NY, USA. achaudhry@novocure.com.
authors.forename: Aafia
authors.initials: A
authors.lastname: Chaudhry
authors.affiliation: Medical Affairs, Novocure Ltd., New York, NY, USA. lbenson@novocure.com.
authors.forename: Laura
authors.initials: L
authors.lastname: Benson
authors.affiliation: Technical Operations, Novocure Ltd., 195 Commerce Way, Portsmouth, NH, USA. mvarshaver@novocure.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Varshaver
authors.affiliation: Research and Development, Novocure Ltd., Topaz Building, 4th Floor, MATAM Center, PO Box 15022, Sha'ar HaCarmel, Haifa, Israel. ofarber@novocure.com.
authors.forename: Ori
authors.initials: O
authors.lastname: Farber
authors.affiliation: Clinical Development, Novocure Ltd., Park 6, CH-6039 Root D4, Lucerne, Switzerland. uweinberg@novocure.com.
authors.forename: Uri
authors.initials: U
authors.lastname: Weinberg
authors.affiliation: Research and Development, Novocure Ltd., Topaz Building, 4th Floor, MATAM Center, PO Box 15022, Sha'ar HaCarmel, Haifa, Israel. ekirson@novocure.com.
authors.forename: Eilon
authors.initials: E
authors.lastname: Kirson
authors.affiliation: Research and Development, Novocure Ltd., Topaz Building, 4th Floor, MATAM Center, PO Box 15022, Sha'ar HaCarmel, Haifa, Israel. ypalti@novocure.com.
authors.forename: Yoram
authors.initials: Y
authors.lastname: Palti
mesh_terms: D001932:Brain Neoplasms / Q000473:pathology* / Q000601:surgery*; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D005909:Glioblastoma / Q000473:pathology* / Q000601:surgery*; D006801:Humans; D008279:Magnetic Resonance Imaging; D015588:Observer Variation; D015203:Reproducibility of Results; D012535:Scalp; D014159:Transducers