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Sponsored by: |
St. Joseph's Hospital, Florida |
Information provided by: | St. Joseph's Hospital, Florida |
ClinicalTrials.gov Identifier: | NCT00152087 |
Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.
Condition | Intervention | Phase |
Liver Cancer |
Device: Brachytherapy |
Phase II |
MedlinePlus related topics: | Cancer Liver Cancer |
ChemIDplus related topics: | TheraSphere |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol. |
Estimated Enrollment: | 25 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | June 2005 |
Protocol Objectives include:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Pritchard, RN, OCN | 813-870-4257 | Mary.Pritchard@baycare.org |
Contact: Ronda Buffington, RN, OCN | 813-870-4123 | Ronda.buffington@baycare.org |
United States, Florida | |||||
St. Joseph's Hospital | Recruiting | ||||
Tampa, Florida, United States, 33607 | |||||
Contact: Ronda Buffington, RN,OCN 813-870-4123 Ronda.Buffington@baycare.org | |||||
Contact: Mary Pritchard, RN, OCN 813-870-4257 Mary.Pritchard@baycare.org |
St. Joseph's Hospital, Florida |
Principal Investigator: | Alison R. Calkins, MD | St. Joseph's Hospital, Tampa, FL |
St Joseph's Hospital web site 
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web site for Dr. Alison Calkins, Investigator 
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Study ID Numbers: | SJCI015, Alison Calkins, MD, Matthew Berlet, MD |
First Received: | September 7, 2005 |
Last Updated: | September 7, 2005 |
ClinicalTrials.gov Identifier: | NCT00152087 |
Health Authority: | United States: Food and Drug Administration |
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