Liver CancerY-90HDENCT00740753
Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option
A study testing Yttrium 90 (TheraSphere) in people with Liver Cancer and Hepatoma, run by OHSU Knight Cancer Institute.
Trial summary
Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatoma
- What is being tested?
- Yttrium 90 (TheraSphere)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to 28 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of HCC
- Cancer is unresectable
- ECOG Score 0-2
- Age of 18 yrs or over
- Able to give consent
Who cannot join
- 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
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- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Pregnancy
About this study
Official title: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.
Read the detailed description
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.
- Conditions
- Liver Cancer, Hepatoma
- Being tested
- Yttrium 90 (TheraSphere)
- Keywords
- liver tumor, cancer, hepatoma, yttrium
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium 90 (TheraSphere)Device
Also called Yttrium - 90, Y-90, TheraSphere
Y-90 embedded glass microspheres
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | yttrium 90 (TheraSphere) administration Receives: Device: Yttrium 90 (TheraSphere) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.
Tumors will decrease in size
Measured: 2 weeks, 1 month and then every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startAug 2004
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth J Kolbeck MD PhD, OHSU Knight Cancer Institute
- Investigators
- Kenneth Kolbeck, MD, PhD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740753
- Sponsor's protocol ID
- IRB00002377
- Other IDs
- HDE 2377
- Acronym
- Y-90HDE
- Status last verified
- Sep 2022
- First submitted
- 22 Aug 2008
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00740753
- Acronym / sponsor ID
- Y-90HDE / IRB00002377
- Conditions
- Liver Cancer, Hepatoma
- Keywords
- liver tumor, cancer, hepatoma, yttrium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, Boston Scientific Corporation
- Study start
- Aug 2004
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Yttrium 90 (TheraSphere)yttrium 90 (TheraSphere) administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of HCC
- Cancer is unresectable
- ECOG Score 0-2
- Age of 18 yrs or over
- Able to give consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yttrium 90 (TheraSphere)Also: Yttrium - 90, Y-90, TheraSphereY-90 embedded glass microspheres | Device | Treatment |
Primary outcome
Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.
Time frame: 2 weeks, 1 month and then every 3 months
Tumors will decrease in size
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Kolbeck, MD, PhD principal investigator
OHSU Knight Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing Yttrium 90 (TheraSphere) in people with Liver Cancer and Hepatoma, run by OHSU Knight Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. (time frame: 2 weeks, 1 month and then every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.