NCT02960620

Brief Summary

This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.

Trial Health

55
Monitor

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

First QC Date

November 8, 2016

Last Update Submit

September 27, 2022

Conditions

Liver CancerLiver NeoplasmsHepatoCellular Carcinoma

Keywords

Humanitarian Device ExemptionLiver DiseaseHDE #980006

Interventions

TheraSphere TreatmentDEVICE

TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.

Eligibility Criteria

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

You may qualify if:

  • Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.
  • Potential candidates are those diagnosed with primary or secondary liver neoplasia. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing Hepatocellular Carcinoma (HCC).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
  • Life expectancy ≥ 3 months
  • \> 4 weeks since prior radiation, surgery or chemotherapy
  • Able to comprehend and provide consent in accordance with institutional and federal guidelines

You may not qualify if:

  • Any other liver therapy planned for cancer treatment
  • Uncorrectable flow to the gastrointestinal tract
  • Estimated radiation doses to the lungs greater than 30 Gy in a single administration or 50 Gy in multiple administrations
  • Significant extrahepatic disease representing imminent life-threatening outcome
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, HepatocellularLiver Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Junsung Choi, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 9, 2016

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations

US(1)