Tissue hyperplasia is one of the most frequently encountered complications when self-expanding metallic stents are placed in benign non-vascular luminal organ strictures, thus causing restenosis of the lumen. The investigators postulated that ionizing irradiation could be applied to prevent restenosis caused by tissue hyperplasia in non-vascular luminal organs as it reduced coronary or peripheral arterial narrowing successfully. The authors combined β-irradiation using 188Re-MAG3 solution with balloon dilation for animal and clinical studies because this new treatment approach had the advantages such as low penetration depth of β-ray, self-centering irradiation, and mechanical effect of balloon dilation over using γ-irradiation with afterloading devices. In this article, the concept and mechanism of radioisotope balloon dilation, and animal and clinical studies using radioisotope balloon dilation are reviewed. (Nucl Med Mol Imaging 2006;40(2):106-112)