RT Journal Article SR Electronic T1 188Re-HDD/Lipiodol Therapy for Hepatocellular Carcinoma: A Phase I Clinical Trial JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP 60 OP 66 VO 46 IS 1 A1 Bieke Lambert A1 Klaus Bacher A1 Luc Defreyne A1 Filip Gemmel A1 Hans Van Vlierberghe A1 Jae Min Jeong A1 Rudi A. Dierckx A1 Christophe Van de Wiele A1 Hubert Thierens A1 Filip De Vos YR 2005 UL http://jnm.snmjournals.org/content/46/1/60.abstract AB The aim of this study was to investigate the pharmacokinetics, organ dosimetry, and toxicity after the intraarterial administration of 188Re-labeled 4-hexadecyl-1,2,9,9-tetramethyl-4,7-diaza-1,10-decanethiol/lipiodol (188Re-HDD/lipiodol) for palliative treatment of hepatocellular carcinoma (HCC). A secondary objective was to document the response. Methods: A mean activity of 3.60 GBq 188Re-HDD/lipiodol (range, 1.86–4.14 GBq) was administered to 11 patients (16 treatment sessions) via a transfemoral catheter. The pharmacokinetic and dosimetric data were collected by means of venous blood samples, urine collections, and 4 or 5 γ-scintigraphies over 76 h. Absorbed doses to the various organs were calculated according to the MIRD formalism, using the MIRDOSE3.1 software. The toxicity was assessed until 6 wk after administration by means of the Common Toxicity Criteria scale. The response was evaluated on MRI and by monitoring of the tumor marker. Results: A fast blood clearance of the injected activity was observed with a calculated effective half-life of 7.6 ± 2.2 h (±SD) in blood. The predominant elimination of the activity was through urinary excretion with a mean renal clearance of 44.1% ± 11.7% (±SD) of the injected activity within the 76 h after administration. Fecal elimination was negligible. The calculated whole-body effective half-life was 14.3 ± 0.9 h (±SD). The absorbed dose to the liver tissue, the lungs, the kidneys, and the thyroid was 4.5 ± 1.9, 4.1 ± 1.2, 0.9 ± 0.7, and 0.3 ± 0.1 Gy, respectively. Treatment was well tolerated, except in 2 patients. One Child B patient experienced a worsening of his liver dysfunction (hyperbilirubinemia) and another patient experienced dyspnea and coughing. Response assessment on MRI showed 1 case of partial response, disease stabilization in 11 treatments, and progressive disease in 1 treatment. In 5 of 8 treatment sessions with an initially elevated α-fetoprotein, a reduction (range, 19%–90%) was observed 6 wk later. Conclusion: After the intraarterial administration of 3.60 GBq 188Re-HDD/lipiodol, a fast clearance of the activity appearing in the blood is observed and the predominant elimination is through urinary excretion. The tolerance as well as the preliminary response rates of the present phase I study are encouraging.