The CDRH Helix: an in vivo evaluation.

The Helix is an electromagnetic heating device used to induce regional/systemic hyperthermia for cancer therapy. It is a resonant device operating at about 82 MHz with an aperture size of 60 cm x 40 cm (elliptical) x 40 cm long. The Helix deposits power in tissues (or phantoms) by producing a predominantly axial electric field within its radiating aperture. Five pig experiments were performed to provide in vivo verification of specific absorption rate (SAR) measurements and electric field measurements which were obtained earlier in tissue-equivalent phantom and 0.9% saline, respectively. In addition to verifying the power deposition patterns found in phantoms, the pig experiments provided valuable insight into the capabilities and limitations of electromagnetic regional heating. For example, a kidney with limited blood flow, simulating a necrotic tumor, heated very well-although the highest temperature was not always measured there. Also, fat heating may be a problem, since excessive temperatures in the fat were observed in approximately 20% of the heatings. This paper compares the in vivo temperature measurements in pigs with SARs and electric field measurements obtained in phantoms, and also provides a brief overview of results of the Helix in clinical situations.