title: An inflatable balloon catheter and liquid 125I radiation source (GliaSite Radiation Therapy System) for treatment of recurrent malignant glioma: multicenter safety and feasibility trial.
abstract: OBJECTIVE
  In this study the authors evaluated the safety and performance of the GliaSite Radiation Therapy System (RTS) in patients with recurrent malignant brain tumors who were undergoing tumor resection.
  
  
  METHODS
  The GliaSite is an inflatable balloon catheter that is placed in the resection cavity at the time of tumor debulking. Low-dose-rate radiation is delivered with an aqueous solution of organically bound iodine-125 (lotrex [sodium 3-(125I)-iodo-4-hydroxybenzenesulfonate]), which are temporarily introduced into the balloon portion of the device via a subcutaneous port. Adults with recurrent malignant glioma underwent resection and GliaSite implantation. One to 2 weeks later, the device was filled with Iotrex for 3 to 6 days, following which the device was explanted. Twenty-one patients with recurrent high-grade astrocytomas were enrolled in the study and received radiation therapy. There were two end points: 1) successful implantation and delivery of brachytherapy; and 2) safety of the device. Implantation of the device, delivery of radiation, and the explantation procedure were well tolerated. At least 40 to 60 Gy was delivered to all tissues within the target volume. There were no serious adverse device-related events during brachytherapy. One patient had a pseudomeningocele, one patient had a wound infection, and three patients had meningitis (one bacterial, one chemical, and one aseptic). No symptomatic radiation necrosis was identified during 21.8 patient-years of follow up. The median survival of previously treated patients was 12.7 months (95% confidence interval 6.9-15.3 months).
  
  
  CONCLUSIONS
  The GliaSite RTS performs safely and efficiently. It delivers a readily quantifiable dose of radiation to tissue at the highest risk for tumor recurrence.
authors.affiliation: Department of Neurosurgery, Wake Forest University, Winston-Salem, North Carolina, USA. jfisher@jhmi.edu
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Tatter
authors.forename: Edward G
authors.initials: EG
authors.lastname: Shaw
authors.forename: Mark L
authors.initials: ML
authors.lastname: Rosenblum
authors.forename: Kastytis C
authors.initials: KC
authors.lastname: Karvelis
authors.forename: Lawrence
authors.initials: L
authors.lastname: Kleinberg
authors.forename: Jon
authors.initials: J
authors.lastname: Weingart
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Olson
authors.forename: Ian R
authors.initials: IR
authors.lastname: Crocker
authors.forename: Steven
authors.initials: S
authors.lastname: Brem
authors.forename: James L
authors.initials: JL
authors.lastname: Pearlman
authors.forename: Joy D
authors.initials: JD
authors.lastname: Fisher
authors.forename: Kathryn
authors.initials: K
authors.lastname: Carson
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Grossman
mesh_terms: D000328:Adult; D000368:Aged; D001557:Benzenesulfonates / Q000008:administration & dosage; D001918:Brachytherapy / Q000009:adverse effects* / Q000295:instrumentation*; D001932:Brain Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D002404:Catheterization / Q000295:instrumentation*; D002408:Catheters, Indwelling; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005910:Glioma / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D007457:Iodine Radioisotopes / Q000008:administration & dosage; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011829:Radiation Dosage
chemical_list: D001557:Benzenesulfonates; D007457:Iodine Radioisotopes; C421459:iotrex