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CC BY 4.0 · World J Nucl Med 2023; 22(02): 114-123
DOI: 10.1055/s-0043-1764306
Original Article

188Re-N-DEDC Lipiodol for Treatment of Hepatocellular Carcinoma (HCC)—A Clinical and Prospective Study to Assess In-Vivo Distribution in Patients and Clinical Feasibility of Therapy

Naresh Kumar
1   Department of Nuclear Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India
,
Priyanka Gupta
1   Department of Nuclear Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India
,
Shamim Ahmed Shamim
1   Department of Nuclear Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India
,
Viju Chirayil 
2   Bhabha Atomic Research Centre, Mumbai, Maharashtra, India
,
Suresh Subramanian 
2   Bhabha Atomic Research Centre, Mumbai, Maharashtra, India
,
Madhava B. Mallia
2   Bhabha Atomic Research Centre, Mumbai, Maharashtra, India
,
Chandrasekhar Bal
1   Department of Nuclear Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India
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Abstract

Objective The incidence of inoperable hepatocellular carcinoma (HCC) with/without malignant portal vein thrombosis (PVT) is increasing in India for the last decade; thus, Bhabha Atomic Research Centre (BARC), Mumbai, India, developed diethydithiocarbamate (DEDC), a new transarterial radionuclide therapy (TART) agent. 188Re-N-DEDC lipiodol is an emerging radiotherapeutic agent for inoperable HCC treatment due to its simple and onsite labeling procedure, cost-effectiveness, and least radiation-induced side effects. This study aimed to evaluate in-vivo biodistribution and clinical feasibility of 188Re-N-DEDC lipiodol TART in HCC and optimization of labeling procedure to assess post-labeling stability and radiochemical yield of labeled lipiodol with 188Re-N-DEDC complex.

Materials and Methods DEDC kits were obtained as gift from BARC, Mumbai. Therapy was given to 31 HCC patients. Post-therapy planar and single-photon emission computed tomography/computed tomography (SPECT/CT) imaging were performed to see tumor uptake and biodistribution. Clinical feasibility and toxicity were decided by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0).

Statistical Analysis Descriptive statistics was done for data using SPSS v22. Values was expressed as mean ± standard deviation or median with range.

Results Post-therapy planar and SPECT/CT imaging showed radiotracer localization in hepatic lesions. Few patients showed lungs uptake due to hepato-pulmonary shunt (lung shunt < 10%). Maximum clearance was observed through urinary tract with very less elimination through hepatobiliary route due to slow rate of leaching of tracer. No patient showed myelosuppression or any other long-term toxicity over median follow-up of 6 months. Mean overall % radiochemical yield of 188Re-N-DEDC lipiodol was 86.04 ± 2.35%. The complex 188Re-N-DEDC was found to be stable at 37°C under sterile condition over a period of 1 hour without any significant change on the % radiochemical purity (90.83 ± 3.24%, 89.78 ± 3.67%, 89.22 ± 3.77% at 0, 0.5, 1 hours, respectively).

Conclusion Human biodistribution showed very high retention of radiotracer in hepatic lesions with no long-term toxicity with this therapy. The kit preparation procedure is ideally suited for a busy hospital radio-pharmacy. By this procedure, 188Re-N-DEDC lipiodol can be prepared in high radiochemical yield within a short time (∼45 minutes). Thus, 188Re-N-DEDC lipiodol can be considered for TART in advanced and/or intermediate HCC.

Keywords

hepatocellular carcinoma (HCC) - trans-arterial radionuclide therapy (TART) - DEDC (diethydithiocarbamate) - radiochemical purity (RCP) - radiochemical yield (RCY)

Authors' Contributions

In this study, seven authors have made their contributions and we hereby certify that there is a significant contribution by all the authors in the study as given below. Naresh Kumar helped in conception and designing of the study, labeling procedure, image acquisition, analysis and data interpretation, and drafting of the manuscript. Shamim Ahmed Shamim conceptualized and designed the study and wrote the manuscript. Priyanka Gupta helped in drafting of the manuscript and data interpretation. Viju Chirayil was involved in conceptualization and designing, and revising manuscript for important intellectual content. Suresh Subramanian and Madhava B. Mallia revised the manuscript for important intellectual content. Chandrasekhar Bal conceptualized and designed the study.


Ethical Approval

The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) of All India Institute of Medical Sciences, New Delhi, India (IECPG-755/23.12.2021, RT-03/27.01.2022). All procedures performed in this study were in accordance with ethical standards of our institute.




Publication History

Article published online:
01 May 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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