Liver CancerNCT02960620
Therasphere for Unresectable Primary or Secondary Liver Neoplasia
A study testing TheraSphere Treatment in people with Liver Cancer and Liver Neoplasms, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Neoplasms, HepatoCellular Carcinoma
- What is being tested?
- TheraSphere Treatment
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006
This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.
- Conditions
- Liver Cancer, Liver Neoplasms, HepatoCellular Carcinoma
- Being tested
- TheraSphere Treatment
- Keywords
- Humanitarian Device Exemption, Liver Disease, HDE #980006
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
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 H. Lee Moffitt Cancer Center and Research 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
- Expanded access
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd, BTG International Inc.
- Responsible party
- Sponsor
- Investigators
- Junsung Choi, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960620
- Sponsor's protocol ID
- MCC-15789
- Status last verified
- Sep 2022
- First submitted
- 8 Nov 2016
- Last updated
- 28 Sep 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006
- ClinicalTrials.gov ID
- NCT02960620
- Acronym / sponsor ID
- MCC-15789
- Conditions
- Liver Cancer, Liver Neoplasms, HepatoCellular Carcinoma
- Keywords
- Humanitarian Device Exemption, Liver Disease, HDE #980006
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd, BTG International Inc.
- First posted
- 9 Nov 2016 (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.
This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| TheraSphere TreatmentTheraSphere® 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. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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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.
Junsung Choi, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSphere Treatment in people with Liver Cancer and Liver Neoplasms, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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.
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 28 Sep 2022.