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Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study

NCT01290536•Nicholas Fidelman, MD

View on ClinicalTrials.gov

Summary

This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
•The cancer is unresectable.
•All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Concurrent therapy with octreotide is permitted, when appropriate.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
•Age 18 years or older.
•Able to understand informed consent.

Exclusion Criteria

•Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
•* single TheraSphere administration; or
•* cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
•Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition.
•Previous radiation therapy to the lungs and/or to the upper abdomen
•Pregnancy
•Symptomatic lung disease.
•Significant extrahepatic disease representing an imminent life-threatening outcome.
•Active uncontrolled infection
•Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
+5 more criteria

Key Dates

Start Date

May 1, 2010

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

March 1, 2019

Enrollment

ACTUAL participants

Conditions

Colorectal NeoplasmsNeuroendocrine TumorsCholangiocarcinomaMelanomaBreast Cancer

Interventions

Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)

DEVICE

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

NCT06662786

Colorectal Neoplasms

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RECRUITINGPHASE2

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

NCT06228066

Small Cell Carcinoma of the BladderHigh Grade Neuroendocrine Tumors of the Urinary Tract

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

Inclusion Criteria

Exclusion Criteria

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors