NCT01556282

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

4.8 years

First QC Date

February 13, 2012

Last Update Submit

May 23, 2014

Conditions

Liver CancerPortal Vein Thrombosis

Keywords

Hepatocellular Carcinomaportal vein thrombosisHCC

Outcome Measures

Primary Outcomes (1)

  • Response rate to the administration of Therasphere

    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.

    Participants will be followed through 1 year after receiving treatment

Study Arms (1)

Therasphere

EXPERIMENTAL
Device: TheraSphere

Interventions

TheraSphereDEVICE

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

Also known as: There are no other names for this device.
Therasphere

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • Xing M, Kokabi N, Camacho JC, Kim HS. Prospective longitudinal quality of life and survival outcomes in patients with advanced infiltrative hepatocellular carcinoma and portal vein thrombosis treated with Yttrium-90 radioembolization. BMC Cancer. 2018 Jan 12;18(1):75. doi: 10.1186/s12885-017-3921-1.

    PMID: 29329568DERIVED

  • Kokabi N, Camacho JC, Xing M, El-Rayes BF, Spivey JR, Knechtle SJ, Kim HS. Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis. Cancer. 2015 Jul 1;121(13):2164-74. doi: 10.1002/cncr.29275. Epub 2015 Apr 6.

    PMID: 25847227DERIVED

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Hyun s Kim, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,FSIR Director of Interventional Radiology and Image Guided Medicine

Study Record Dates

First Submitted

February 13, 2012

First Posted

March 16, 2012

Study Start

March 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

US(1)