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The CDRH helix. A phase I clinical trial
D S Shimm1, T C Cetas, K H Hynynen
1Department of Radiation Oncology, University of Arizona Cancer Center, Tucson 85724.
American Journal of Clinical Oncology
|April 1, 1989
Summary
Regional hyperthermia using the CDRH Helix device showed limited effectiveness in heating large tumors. While easier to use than alternatives, it did not consistently achieve clinically useful temperatures for cancer treatment.
Area of Science:
- Oncology
- Medical Physics
- Biomedical Engineering
Background:
- Regional hyperthermia is an adjunct cancer therapy.
- Advanced tumor treatments require effective heating modalities.
- The Center for Devices and Radiologic Health (CDRH) Helix is a resonant helical coil for hyperthermia.
Purpose of the Study:
- To evaluate the efficacy of the CDRH Helix device in regional hyperthermia treatments.
- To compare the pelvic heating capabilities of the CDRH Helix with the BSD-1000 annular phased array.
- To assess the clinical usability and temperature generation of the CDRH Helix.
Main Methods:
- Seventeen patients with large, advanced tumors received regional hyperthermia using the CDRH Helix.
- Temperature measurements (maximum, minimum, average) were recorded.
- Pelvic heating was compared between the CDRH Helix and BSD-1000.
Main Results:
- Mean tumor volume exceeded 1000 cc.
- Average temperatures achieved were 40.6°C (max), 38.6°C (min), and 39.6°C (avg).
- The CDRH Helix and BSD-1000 showed equivalent pelvic heating; Helix was more user-friendly.
Conclusions:
- Neither the CDRH Helix nor the BSD-1000 consistently produced clinically useful hyperthermia temperatures.
- The CDRH Helix device is under investigation for combined regional-systemic hyperthermia therapies.