Background: Selective internal radiation therapy (SIRT) with yttrium-90 (Y) resin microspheres is an established locoregional treatment option for unresectable hepatocellular carcinoma (HCC), which delivers a lethal dose of radiation to hepatic tumors, while sparing surrounding healthy tissue. DOORwaY90 is a prospective, multicenter, open-label, single arm study, designed to evaluate the safety and effectiveness of Y resin microspheres as first-line treatment in patients with unresectable/unablatable HCC. It is unique in that it is the first study with resin microspheres to utilize a personalized Y dosimetry approach, and independent review for treatment planning and response assessment.
Methods: Eligibility criteria include unresectable/unablatable HCC, Barcelona Clinic Liver Cancer stage A, B1, B2, or C with a maximal single tumor diameter of ≤ 8 cm, and a sum of maximal tumor diameters of ≤ 12 cm, and at least one tumor ≥ 2 cm (long axis) per localized, modified Response Evaluation Criteria in Solid Tumors. Partition model dosimetry is used to determine the optimal dose; the target mean dose to tumor is ≥ 150 Gy. Patients are assessed at baseline and at regular intervals up until 12 months of treatment for response rates, safety, and quality of life (QoL). Post-treatment dosimetry is used to assess dose delivered to tumor and consider if retreatment is necessary. The co-primary endpoints are best objective response rate and duration of response. Secondary endpoints include grade ≥ 3 toxicity, QoL, and incidence of liver resection and transplantation post SIRT. Target recruitment is 100 patients.
Discussion: The results of this trial should provide further information on the potential use of SIRT with Y resin microspheres as first-line therapy for unresectable HCC.
Trial Registration: Clinicaltrials.gov; NCT04736121; date of 1st registration, January 27, 2021, https://clinicaltrials.gov/ct2/show/NCT04736121 .
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8962126 | PMC |
| http://dx.doi.org/10.1186/s12876-022-02204-1 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
N-chlorination of urea-formaldehyde resin microspheres for antibacterial regenerated cellulose fibers.
Int J Biol Macromol
January 2025
Institute of Functional Textiles and Advanced Materials, College of Textiles & Clothing, Qingdao Key Laboratory of Flame-Retardant Textile Materials, State Key Laboratory of Bio-fibers and Eco-textiles, Qingdao University, Qingdao 266071, China. Electronic address:
Regenerated cellulose fibers are required for widespread antibacterial applications across various fields. N-halamines have been extensively studied and are regarded as a promising candidate for antibacterial purposes. In this work, we focus on investigating the chlorination performance of urea-formaldehyde resin microspheres (UFRs) and using them as antibacterial additives incorporated into the spinning dope to fabricate antibacterial viscose fibers.
View Article and Find Full Text PDFTransarterial Radioembolization with Yttrium-90 Resin Microspheres for Huge Focal Nodular Hyperplasia.
Cardiovasc Intervent Radiol
December 2024
Ytrrium-90 Precision Interventional Radiotherapy Center of Liver Cancer, SchoolofClinicalMedicine, Beijing Tsinghua Changgung Hospital, TsinghuaUniversity, Beijing, China.
Recapitulation of physiologic and pathophysiologic pulsatile CSF flow in purpose-built high-throughput hydrocephalus bioreactors.
Fluids Barriers CNS
December 2024
Department of Chemical Engineering and Materials Science, Wayne State University, 6135 Woodward Avenue, Rm 1413, Detroit, MI, 48202, USA.
Background: Hydrocephalus, an accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain, is often treated via a shunt system to divert the excess CSF to a different compartment; if left untreated, it can lead to serious complications and permanent brain damage. It is estimated that one in every 500 people are born with hydrocephalus. Despite more than 60 years of concerted efforts, shunts still have the highest failure rate of any neurological device requiring follow-up shunt revision surgeries and contributing to the $2 billion cost of hydrocephalus care in the US alone.
View Article and Find Full Text PDFConstructing High-Performance Composite Epoxy Resins: Interfacial π-π Stacking Interactions-Driven Physical Rolling Behavior of Silica Microspheres.
Adv Mater
December 2024
School of Materials and Chemistry and State Key Laboratory of Environment-friendly Energy Materials, Southwest University of Science and Technology, 59, Middle Qinglong Avenue, Mianyang, 621010, P. R. China.
The intrinsic compromise between strength and toughness in composite epoxy resins significantly constrains their practical applications. In this study, a novel strategy is introduced, leveraging interfacial π-π stacking interactions to induce the "rolling behavior" of microsphere fillers, thereby facilitating efficient energy dissipation. This approach is corroborated through theoretical simulations and experimental validation.
View Article and Find Full Text PDFPrediction of left lobe hypertrophy with voxel-based dosimetry using integrated Y-90 PET/MRI after radioembolization of liver tumors with Y-90 microspheres.
Eur J Nucl Med Mol Imaging
December 2024
Ankara University Medical School Department of Nuclear Medicine, Ankara, Turkey.
Purpose: The aim of this study was to investigate the relationship between voxel-based dosimetric variables derived from Y-90 PET/MRI and hypertrophy observed in the left lobe after radioembolization and to investigate if there is any difference in hypertrophy induced by glass versus resin microspheres.
Methods: Voxel-based dosimetry-derived variables and their relationship with the change of the standardized future liver remnant (ΔFLR) was investigated with linear regression models. To compare and evaluate the discriminatory power of the dosimetric variables, ROC analyses were utilized.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!