Hepatocellular CarcinomaNCT05233098
TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.
An observational study of Hepatocellular Carcinoma, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Technetium-99m macroaggregated albumin (Tc-99m MAA)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 14 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Adult, Older adult
Study population: The intended population for the TheraSphere Post-Approval study is patients with HCC who are undergoing evaluation to assess eligibility for TheraSphere treatment.
Who may be able to join
- Patients 21 years and older
- Written informed consent
- Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.
Who cannot join
- Patients who are contraindicated for TheraSphere treatment.
- Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert.
- Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TheraSphere Post-approval Study to Calculate the Radiation-absorbed Dose of Technetium-99m Macroaggregated Albumin (Tc-99m MAA) to the Whole Body and Non-liver Critical Organs.
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
Read the detailed description
Every patient being treated with TheraSphere needs to have a screening procedure with the administration of a radioactive product named Tc-99m MAA (called pre-treatment mapping). This screening procedure aims to determine if the patient can be treated with TheraSphere. The purpose of this study is to better understand the dose of radiation that is absorbed by the body and the risk of Tc-99m MAA to the whole body and other organs around the liver. The study will determine the amount of Tc-99m MAA that stays in the body and organs up to 24 hours after the administration.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Technetium-99m macroaggregated albumin (Tc-99m MAA)
- Keywords
- Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Liver Diseases
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium-99m macroaggregated albumin (Tc-99m MAA)Device
Patients who are being evaluated for TheraSphere administration.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Cohort | Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. Receives: Device: Technetium-99m macroaggregated albumin (Tc-99m MAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.
Measured: Immediately following
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Measured: Immediately following
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.
Measured: 4 hours +/- 2 hours
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Measured: 4 hours +/- 2 hours
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.
Measured: 18-24 hours
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Measured: 18-24 hours
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.
Measured: Overall
Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.
Measured: Overall
Effective Dose of Tc-99m MAA (mSv) Whole Body
To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.
Measured: Overall
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body
To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.
Measured: Overall
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs
To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.
Measured: Overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start4 Apr 2022
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Riad Salem, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233098
- Sponsor's protocol ID
- S2494
- Status last verified
- Jul 2024
- First submitted
- 20 Jan 2022
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheraSphere Post-approval Study to Calculate the Radiation-absorbed Dose of Technetium-99m Macroaggregated Albumin (Tc-99m MAA) to the Whole Body and Non-liver Critical Organs.
- ClinicalTrials.gov ID
- NCT05233098
- Acronym / sponsor ID
- S2494
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
Detailed description
Every patient being treated with TheraSphere needs to have a screening procedure with the administration of a radioactive product named Tc-99m MAA (called pre-treatment mapping). This screening procedure aims to determine if the patient can be treated with TheraSphere. The purpose of this study is to better understand the dose of radiation that is absorbed by the body and the risk of Tc-99m MAA to the whole body and other organs around the liver. The study will determine the amount of Tc-99m MAA that stays in the body and organs up to 24 hours after the administration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Cohort | – | Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The intended population for the TheraSphere Post-Approval study is patients with HCC who are undergoing evaluation to assess eligibility for TheraSphere treatment.
Key inclusion criteria (3 listed)
- Patients 21 years and older
- Written informed consent
- Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.
Key exclusion criteria (3 listed)
- Patients who are contraindicated for TheraSphere treatment.
- Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert.
- Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping
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 |
|---|---|---|
| Technetium-99m macroaggregated albumin (Tc-99m MAA)Patients who are being evaluated for TheraSphere administration. | Device | Clinical Cohort |
Primary outcome
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
Time frame: Immediately following
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
Time frame: Immediately following
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
Time frame: 4 hours +/- 2 hours
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.
Time frame: 4 hours +/- 2 hours
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.
Time frame: 18-24 hours
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
Time frame: 18-24 hours
To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.
Time frame: Overall
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.
Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs
Time frame: Overall
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.
Effective Dose of Tc-99m MAA (mSv) Whole Body
Time frame: Overall
To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body
Time frame: Overall
To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs
Time frame: Overall
To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Riad Salem, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Boston Scientific Corporation 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 3 inclusion and 3 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 6 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Delivered Activity of Tc-99m MAA (MBq) for Whole Body (time frame: Immediately following). The study lists 11 primary outcomes in all. 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 6 Mar 2025.