Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT00605150
Brief 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.
Detailed Description:
The objectives of this study are to provide supervised access to treatment with TheraSphere to eligible patients with Hepatocellular Carcinoma of the liver who are not surgical resection candidates and to evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
This is an observational treatment use protocol that will provide Institutional Review Board (IRB) oversight and documentation of the clinical experience of patients undergoing treatment for liver carcinoma using TheraSphere. Participation involves no investigational or research procedures. Patients will be followed for treatment-related adverse experiences and will be monitored in accordance with institutional practices. Approximately 60 patients will be enrolled in a treatment protocol and the number may be expanded following completion of the first cohort. The total number of patients to be treated will be determined based on clinical experience and patient outcomes. There are no control subjects in this treatment protocol.
The duration of the protocol will depend on patient experience with this treatment. An initial one year approval is sought at this time. Patient experience will be evaluated continuously and if the clinicians find that the treatment provides benefits to patients, renewal of the approval will be sought after the first 12 months.
Study:
NCT00605150
Study Brief:
Protocol Section:
NCT00605150