title: The CDRH helix. A phase I clinical trial.
abstract: Seventeen patients have been given regional hyperthermia treatments using the Center for Devices and Radiologic Health (CDRH) Helix, a resonant helical coil unit. Most of these patients had large, clinically advanced tumors, whose mean volume exceeded 1000 cc. Mean maximum, minimum, and average temperatures were 40.6, 38.6, and 39.6 degrees C, respectively, for all sites combined. The pelvic heating capabilities of the CDRH Helix and the BSD-1000 annular phased array were compared, and generally were equivalent. Although the Helix could be used in a wider variety of locations, and was more comfortable and easier to use than the BSD-1000 annular phased array, neither device was particularly effective in generating clinically useful temperatures; the Helix is currently under investigation for use in regional-systemic hyperthermia in combination with antineoplastic drugs and biologic response modifiers.
authors.affiliation: Department of Radiation Oncology, University of Arizona Cancer Center, Tucson 85724.
authors.forename: D S
authors.initials: DS
authors.lastname: Shimm
authors.forename: T C
authors.initials: TC
authors.lastname: Cetas
authors.forename: K H
authors.initials: KH
authors.lastname: Hynynen
authors.forename: D N
authors.initials: DN
authors.lastname: Buechler
authors.forename: D P
authors.initials: DP
authors.lastname: Anhalt
authors.forename: H F
authors.initials: HF
authors.lastname: Sykes
authors.forename: J R
authors.initials: JR
authors.lastname: Cassady
mesh_terms: D002985:Clinical Protocols; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000295:instrumentation* / Q000379:methods; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy; D010386:Pelvic Neoplasms / Q000628:therapy; D013821:Thermometers