CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
TheraSphere-Yttrium 90 microsphereradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00605150
NCT00605150N/ACompleted
CompareCT.gov

A Humanitarian Device Exemption (HDE) Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

Wake Forest University Health Sciences·observational·Posted Jan 30, 2008·Updated Apr 22, 2022

In Brief

An observational study evaluating TheraSphere-Yttrium 90 microsphere for Hepatocellular Carcinoma. Completed, enrolled 11 participants.

Detailed Summary

MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System Institutional Review Board.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.4 years ago

Interventions

TheraSphere-Yttrium 90 microsphereradiation

TheraSphere is delivered to the liver via a catheter placed into the femoral artery and guided by fluoroscopy to the hepatic artery. Once the catheter is properly positioned, the physician infuses TheraSphere, which localizes preferentially in the tumor.