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PGI trial for ₹5,000 liver cancer treatment begins in April
To be boon for patients as internationally established Y-90 costs ₹10 lakh, say experts; the trial will begin at PGIMER-Chandigarh, AIIMS-New Delhi, AIIMS-Bhubaneshwar, JIPMER-Puducherry and TATA Memorial Hospital in Mumbai
A three-year clinical trial of an indigenously developed radioactive therapy for liver cancer — costing just ₹5,000, far lower than the internationally established Yttrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) that costs ₹10 lakh — will begin at the Postgraduate Institute of Medical Education and Research (PGIMER) in April. Called “transarterial radionuclide therapy”, it will be a boon for poor patients since Y-90 SIRT is out of their reach due to its high cost, experts said.
Successful completion of the trial will demonstrate that indigenous Rhenium-188 (Re-188) microspheres is comparable to internationally established Y-90 spheres for the treatment of liver cancer. This will promote national recognition and affordability of the therapy improving patient access, survival and quality of life.
The transarterial radionuclide therapy has been developed and patented by Prof Jaya Shukla of PGIMER’s nuclear medicine department. The therapy has been available at PGIMER since 2013 and has been administered to 60 inoperable liver cancer patients. The treatment remained limited to PGI all these years due to the complex process of making the dosage and the patents of therapy not making it to the commercial market.
Now, with ₹7 crore funding from the Indian Council of Medical Research, PGIMER is set to start the multi-centric clinical trial from April onwards. The treatment is multidisciplinary, involving nuclear medicine, hepatology and radiology department. The trial is scheduled to begin in five hospitals — PGIMER-Chandigarh, AIIMS-New Delhi, AIIMS-Bhubaneshwar, JIPMER-Puducherry and TATA Memorial Hospital in Mumbai.
The inoperable liver cancer patients who fall in the inclusion criteria of the trial will be treated free of cost in these hospitals. PGIMER is ready with the completion of treatment protocol and clearance from ethics committee. The institute is in the final stage of procuring the Rhenium-188 for the therapy.
Prof Jaya said, “Hepatocellular carcinoma (HCC) is is a leading cause of cancer-related deaths in the world. The incidence of liver cancer has risen steadily, with projections estimating 55% increase by 2040. The main causes of liver cancer are chronic viral hepatitis, alcohol use and chronic liver disease. In India, HCC represents a substantial cancer burden and is often diagnosed at an advanced stage.”
The incidence of liver cancer in India is 2.15 per 1 lakh while the mortality rate is 2.21 per lakh and prevalence rate 2.27 per one lakh, as per a study — “Epidemiology of HCC in India: an updated review for 2024” — published in Science Direct’s Journal of Clinical and Experimental Hepatology.
About the therapy
The radioactive therapies are applicable to hepatocellular carcinoma, the most common type of primary liver cancer among patients whose tumour can’t be removed by surgery and is confined to liver. Radiation is used to damage the tumour without harming the healthy cells.
Similar to Y-90 spheres, Prof Jaya developed Rhenium-188 microspheres and patented a microsphere cold kit that allows in-house preparation of Rhenium188 microsphere therapeutic doses just before the treatment. Hospitals can procure Re-188 generator that can be used up to 6 months. Working on the microsphere formulation since 2011, Dr Shukla patented her Rhenium-188 microsphere technology in 2021 and microsphere cold-kit in 2023.
