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OpenTrials
Completed

NCT Number: NCT01556282

TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therasphere

Device

TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.

Other names: There are no other names for this device.

Primary outcomes

  1. 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

Secondary outcomes

  1. Progression free survival for patients with unresectable liver cancer.

    Time frame: Participants will be followed through 1 year after receiving treatment

    Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 16, 2012
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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