TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis
This study is currently recruiting participants.
Verified October 2012 by Emory University
Sponsor:
Emory University
Information provided by (Responsible Party):
Hyun Kevin Kim, Emory University
ClinicalTrials.gov Identifier:
NCT01556282
First received: February 13, 2012
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.
| Condition | Intervention |
|---|---|
|
Liver Cancer Portal Vein Thrombosis |
Device: TheraSphere |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis |
Resource links provided by NLM:
Further study details as provided by Emory University:
Primary Outcome Measures:
- Response rate to the administration of Therasphere [ Time Frame: Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival for patients with unresectable liver cancer. [ Time Frame: Participants will be followed through 1 year after receiving treatment ] [ Designated as safety issue: No ]Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Therasphere |
Device: TheraSphere
TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
Other Name: There are no other names for this device.
|
Detailed Description:
Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.
Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 yrs of age or older
- Diagnosis of Hepatocellular Carcinoma
- Portal Vein Thrombosis
ECOG performance < 2
->4 weeks since prior radiation, surgery or chemotherapy.
- Life expectancy > 3 months
- Able to provide written informed consent process in accordance with institutional review boards guidelines.
Exclusion Criteria:
- Contraindications to angiography and selective visceral catheterization.
- Evidence of blood flow to the lung from the liver greater than 16.5 mCi
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
- Significant extrahepatic disease.
- Severe liver disfunction of pulmonary insufficiency.
- Active uncontrolled infection.
- Significant underlying medical or psychiatric illness.
- Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556282
Contacts
| Contact: Maria V Rivas | (404) 712-7962 | mrivas2@emory.edu |
| Contact: Kevin S. Kim, MD | (404) 712-7033 | hkim286@emory.edu |
Locations
| United States, Georgia | |
| Emory University Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Hyun S Kim, MD,FSIR | |
Sponsors and Collaborators
Emory University
Investigators
| Principal Investigator: | Hyun s Kim, MD | Emory University |
More Information
No publications provided
| Responsible Party: | Hyun Kevin Kim, MD,FSIR Director of Interventional Radiology and Image Guided Medicine, Emory University |
| ClinicalTrials.gov Identifier: | NCT01556282 History of Changes |
| Other Study ID Numbers: | 00015167 |
| Study First Received: | February 13, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Hepatocellular Carcinoma portal vein thrombosis HCC |
Additional relevant MeSH terms:
|
Liver Neoplasms Thrombosis Venous Thrombosis Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Liver Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013