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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Liver Cancer, Hepatoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.

Outcome Time Frame:

2 weeks, 1 month and then every 3 months

Safety Issue:

Yes

Principal Investigator

John A Kaufman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dotter Interventional Institute Oregon Health & Science University

Authority:

United States: Institutional Review Board

Study ID:

HDE 2377

NCT ID:

NCT00740753

Start Date:

August 2004

Completion Date:

January 2020

Related Keywords:

  • Liver Cancer
  • Hepatoma
  • liver tumor
  • cancer
  • hepatoma
  • yttrium
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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