Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option (Y-90HDE)

• ClinicalTrials.gov Identifier: NCT00740753
• Recruitment Status: Completed
• First Posted: August 25, 2008
• Last Update Posted: September 30, 2022
• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; Boston Scientific Corporation
• Information provided by (Responsible Party): Kenneth J Kolbeck MD PhD, OHSU Knight Cancer Institute

Tracking Information

• First Submitted Date: August 22, 2008
• First Posted Date: August 25, 2008
• Last Update Posted Date: September 30, 2022
• Study Start Date: August 2004
• Actual Primary Completion Date: April 28, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2017)

Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. [ Time Frame: 2 weeks, 1 month and then every 3 months ]

Tumors will decrease in size

• Original Primary Outcome Measures (submitted: August 22, 2008): Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. [ Time Frame: 2 weeks, 1 month and then every 3 months ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option
• Official Title: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
• Brief Summary: Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.
• Detailed Description: Patients receive Y-90 (yttrium) glass microspheres via percutaneous hepatic arterial infusion. Patients amy be retreated between 30-90 days after initial infusion. After completion of therapy, patients are followed for 30 days and then every 3 months for up to 2 years.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Liver Cancer
• Hepatoma

Intervention

Device: Yttrium 90 (TheraSphere)

Y-90 embedded glass microspheres

Other Names:

• Yttrium - 90
• Y-90
• TheraSphere

Study Arms

Treatment

yttrium 90 (TheraSphere) administration

Intervention: Device: Yttrium 90 (TheraSphere)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 14, 2021): 339
• Original Estimated Enrollment (submitted: August 22, 2008): 250
• Actual Study Completion Date: April 28, 2021
• Actual Primary Completion Date: April 28, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Confirmed diagnosis of HCC
• Cancer is unresectable
• ECOG Score 0-2
• Age of 18 yrs or over
• Able to give consent

Exclusion Criteria:

• Contraindication to angiography and selective visceral catheterization
• Portal hypertension with portal venous shunt away from the liver
• Evidence of potential delivery of > 16.5 mCi of radiation to the lungs
• Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00740753
• Other Study ID Numbers: IRB00002377; HDE 2377 ( Other Identifier: Oregon Health & Science University )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kenneth J Kolbeck MD PhD, OHSU Knight Cancer Institute
• Original Responsible Party: John A. Kaufman MD, Dotter Interventional Institute, Oregon Health and Science University
• Current Study Sponsor: OHSU Knight Cancer Institute
• Original Study Sponsor: Oregon Health and Science University

Collaborators

• Oregon Health and Science University
• Boston Scientific Corporation

Investigators

• Principal Investigator: Kenneth Kolbeck, MD, PhD; OHSU Knight Cancer Institute

• PRS Account: OHSU Knight Cancer Institute
• Verification Date: September 2022