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Yttrium 90 glass microspheres · 1 trial · 3 indications
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
| Arm | Type | Description |
|---|---|---|
| TheraSphere | EXPERIMENTAL | Single arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer |
| Name | Type | Description |
|---|---|---|
| Yttrium 90 glass microspheres | DEVICE | 120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe |
Inclusion Criteria: * 18 years of age or older * diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies * unresectable liver metastases * target tumors measurable using standard imaging techniques * tumor replacement \< o...
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Yttrium 90 glass microspheres are used for the treatment of liver metastases in patients with colorectal cancer. They are administered directly to the liver to deliver localized radiation. This therapy is being studied in an investigational setting and is not yet approved for this indication.
Yttrium 90 glass microspheres are developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical research to evaluate the safety and efficacy of this treatment for liver metastases.
Yttrium 90 glass microspheres are in Phase 2 clinical development for the treatment of liver metastases in colorectal cancer. The therapy is investigational and has not received FDA approval. One Phase 2 trial has been completed, with results not yet reported.
Yttrium 90 glass microspheres have been studied in one completed Phase 2 clinical trial, identified as NCT00511862, titled "TheraSphere for the Treatment of Liver Metastases." The trial enrolled 151 participants in the United States and included patients with colorectal cancer, neuroendocrine carcinoma, and other metastatic conditions.
Yes, Yttrium 90 glass microspheres are also known as TheraSphere. The completed clinical trial NCT00511862 uses the name TheraSphere to refer to this treatment. This alternative name is commonly used in clinical research and medical literature.