NCT01349075

Brief Summary

TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere), it can be injected into the liver through a blood vessel. This allows a large local dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
474

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

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

October 1, 2007

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

13.5 years

First QC Date

May 4, 2011

Last Update Submit

April 28, 2025

Conditions

Hepatocellular Carcinoma

Keywords

UnresectableHepatocellular CarcinomaTheraSphereYttrium-90

Outcome Measures

Primary Outcomes (1)

  • Response to Treatment

    Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist. The principal clinician will be able to get a preliminary evaluation of tumor response in patients who return for subsequent treatment, as part of the imaging studies required for repeat safety screening of patients.

    Through 24 months post-treatment

Secondary Outcomes (2)

  • Safety

    Through 24 months post-treatment or death

  • Survival Time

    Through 24 months post-treatment or death

Study Arms (1)

TheraSphere

Radiation: TheraSphere

Interventions

TheraSphereRADIATION

The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used.

Also known as: Yttrium-90
TheraSphere

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.

You may qualify if:

  • Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver
  • Patients who are able to give informed consent, will be eligible.
  • Patients must have an ECOG Performance Status score of \< or = 2
  • Must have a life expectancy of \> 3 months
  • Non-pregnant with an acceptable contraception in premenopausal women
  • Patients must be \> 4 weeks since prior radiation or prior surgery and at least 1 month post chemotherapy

You may not qualify if:

  • Contraindications to angiography and selective visceral catheterization
  • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment 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 or mitigate such flow (ex. placing catheter distal to gastric vessels)
  • 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
  • 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)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Yttrium-90

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Colette Shaw, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 6, 2011

Study Start

October 1, 2007

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

US(1)