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Preliminary results of the Phase 1 Lip-Re I clinical trial biodistribution and dosimetry assessments in hepatocellular carcinoma patients treated with Re-SSS Lipiodol radioembolization

Abstract : Purpose This study sought to provide preliminary results on the biodistribution and dosimetry following intra-arterial liver injection of Re-188-SSS Lipiodol on hepatocellular carcinoma patients included in the Phase I Lip-Re 1 study. Methods Results of the first six patients included are reported. Analysis of the Re-188-SSS Lipiodol biodistribution was based on planar scintigraphic and tomoscintigraphic (SPECT) studies performed at 1, 6, 24, 48, and 72h post-administration. Quantification in blood, urine, and stool samples was performed. Determination of the tumour to non-tumour uptake ratio (T/NT) was calculated. Absorbed doses to target organs and tumours were evaluated using the MIRD formalism. Results The mean injected activity of Re-188-SSS Lipiodol was 1645361MBq. Uptakes were seen in the liver (tumour and healthy liver) and the lungs only. All these uptakes were stable over time. A mean 1.4 +/- 0.7% of Re-188-SSS Lipiodol administered was detected in serum samples at 6h, declining rapidly thereafter. On average, 1.5 +/- 1.6% of administered activity was eliminated in urine and feces over 72h. Overall, 90.7 +/- 1.6% of detected activity on SPECT studies was found in the liver (74.9 +/- 1.8% in tumours and 19.1 +/- 1.7% in the healthy liver) and 9.3 +/- 1.6% in the lungs (5.7 +/- 1.1% in right and 3.7 +/- 0.5% in left lungs). Mean doses absorbed were 7.9 +/- 3.7Gy to the whole liver, 42.7 +/- 34.0Gy to the tumours, 10.2 +/- 3.7Gy to the healthy liver, and 1.5 +/- 1.2Gy to the lungs. Four patients had stable disease on CT scans at 2months. The first patient with rapidly progressive disease died at 1month, most probably of massive tumour progression. Due to this early death and using a conservative approach, the trial independent evaluation committee decided to consider this event as a treatment-related toxicity. Conclusion 188Re-SSS Lipiodol has a favorable biodistribution profile concerning radioembolization, with the highest in-vivo stability among all radiolabeled Lipiodol compounds reported to date. These preliminary results must be further confirmed while completing this Phase I Lip Re1 study.
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-02049701
Contributor : Laurent Jonchère <>
Submitted on : Tuesday, February 26, 2019 - 3:30:26 PM
Last modification on : Friday, October 16, 2020 - 3:34:47 AM

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Kostas Delaunay, Julien Edeline, Yan Rolland, Nicolas Lepareur, Sophie Laffont, et al.. Preliminary results of the Phase 1 Lip-Re I clinical trial biodistribution and dosimetry assessments in hepatocellular carcinoma patients treated with Re-SSS Lipiodol radioembolization. European Journal of Nuclear Medicine and Molecular Imaging, Springer Verlag (Germany), 2019, 46 (7), pp.1506-1517. ⟨10.1007/s00259-019-04277-9⟩. ⟨hal-02049701⟩

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