📊 Evidence-Based Reference

therasphere

Boston Scientific

Summary: TheraSphere is a device used for selective internal radiation therapy in patients with unresectable hepatocellular carcinoma. Key evidence highlights its use in improving local tumor control.

FDA Clearance Information

Pathway PMA

Number P200029 ↗

Decision Date March 17, 2021

Product Code NAW

Device Class Class 3

Evidence 14 studies

TheraSphere received FDA premarket approval (PMA) on March 17, 2021. Manufactured by Boston Scientific, it is classified as a Class 3 device.

What It Is

TheraSphere is a medical device that delivers yttrium-90 glass microspheres for selective internal radiation therapy. It is intended for local tumor control in patients with unresectable hepatocellular carcinoma.

Clinical Applications

TheraSphere is commonly used in patients with solitary tumors in the liver, particularly those with hepatocellular carcinoma who are not candidates for surgical resection. It is applied in cases with well-compensated liver function and no macrovascular invasion.

Evidence Summary

The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from 2022 to 2025, focusing on the efficacy and safety of TheraSphere.

Reported Outcomes

Published studies report that TheraSphere is effective in improving local tumor control in hepatocellular carcinoma. It has been shown to be beneficial in combination with chemotherapy for certain liver cancers. Cost-effectiveness analyses suggest personalized dosimetry may enhance outcomes.

Safety Profile

Reported complications include potential radiation-induced liver disease and other liver-related adverse events. However, the overall safety profile is considered acceptable within the studied patient populations.

Evidence Limitations

The evidence is limited by the lack of large-scale randomized controlled trials directly comparing TheraSphere to other treatment modalities. Further research is needed to explore long-term outcomes and optimal dosimetry strategies.

Linked Studies (14)

PubMed • 2025

TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial.

JMIR research protocols

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2025

Clinical and dosimetric considerations for yttrium-90 glass microspheres radioembolization of intrahepatic cholangiocarcinoma, metastatic colorectal carcinoma, and metastatic neuroendocrine carcinoma: recommendations from an international multidisciplinary working group.

European journal of nuclear medicine and molecular imaging

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2023

Clinical, dosimetric, and reporting considerations for Y-90 glass microspheres in hepatocellular carcinoma: updated 2022 recommendations from an international multidisciplinary working group.

European journal of nuclear medicine and molecular imaging

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2022

Cost-effectiveness analysis of personalised versus standard dosimetry for selective internal radiation therapy with TheraSphere in patients with hepatocellular carcinoma.

Frontiers in oncology

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2021

The cost-effectiveness of TheraSphere in patients with hepatocellular carcinoma who are eligible for transarterial embolization.

European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2018

Comparison of the Adverse Event Profile of TheraSphere® with SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma: A Systematic Review.

Cardiovascular and interventional radiology

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2016

Outcomes of Therasphere Radioembolization for Colorectal Metastases.

Clinical colorectal cancer

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2011

Radioembolization for hepatocellular carcinoma using TheraSphere®.

Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2009

Yttrium-90 radioembolization using TheraSphere in the management of primary and secondary liver tumors.

The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of...

RCT|prospective|retrospective|case Series|other View Source →

PubMed • 2007

Yttrium-90 microspheres (TheraSphere and SIR-Spheres) for the treatment of unresectable hepatocellular carcinoma.

Issues in emerging health technologies

RCT|prospective|retrospective|case Series|other View Source →

ClinicalTrials.gov

Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

View Source →

ClinicalTrials.gov

TheraSphere® For Treatment of Metastases in Liver

View Source →

ClinicalTrials.gov

TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

View Source →

ClinicalTrials.gov

Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry

View Source →

Frequently Asked Questions

What are the clinical indications for TheraSphere?

TheraSphere is indicated for selective internal radiation therapy in patients with unresectable hepatocellular carcinoma, Child-Pugh Score A cirrhosis, and well-compensated liver function.

What outcomes have been reported in clinical studies?

Studies have reported improved local tumor control and potential benefits when combined with chemotherapy. Personalized dosimetry may enhance cost-effectiveness.

What complications have been reported?

Reported complications include radiation-induced liver disease and other liver-related adverse events, though the safety profile is generally acceptable.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.