Hepatocellular CarcinomaRECORDNCT05111795
Holmium-166 Retrospective Collection of Real-World Data
An observational study of Hepatocellular Carcinoma and Metastatic Cancer, run by Terumo Europe N.V. at 12 sites in 7 countries.
Trial summary
The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Metastatic Cancer
- What is being tested?
- Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 17 Jan 2022to 8 Apr 2022
- Phase
- Observational
- 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
Study population: The population to be included has been treated at the top-ordering hospitals for QuiremSpheresTM Holmium-166 Microspheres. All patients treated at these hospitals between 15 July 2019 and 15 July 2021 are aimed to be included.
Who may be able to join
- Patient with diagnosis of primary liver tumor or metastases in the liver.
- Patients treated with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres from 15 July 2019 to 15 July 2021.
- Patient is ≥ 18 years.
- If required by national regulation, patient has understood and signed written informed consent to retrospective data collection.
Who cannot join
- Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Germany4 sites
Universitätsklinikum Carl Gustav Carus
Dresden
Klinikum Herford
Herford
Universitätsklinikum Jena
Jena
Universitätsmedizin Rostock
Rostock
Portugal1 site
Instituto Português De Oncologia Do Porto Francisco Gentil, EPE
Porto
About this study
The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.
Read the detailed description
This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.
- Conditions
- Hepatocellular Carcinoma, Metastatic Cancer
- Being tested
- Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 MicrospheresDevice
Also called SIRT, Radioembolization, TARE
SIRT work-up procedure and SIRT procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of Adverse Events
The primary safety endpoint is defined in terms of incidence of adverse events CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 3, or any grade of a predefined list of events stemming from risk management of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres.
Measured: 30 months
Progression Free Survival (PFS)
Time from SIRT procedure until overall progression or death
Measured: 30 months
Hepatic Progression Free Survival (HPFS)
Time from SIRT procedure until progression in the liver or death
Measured: 30 months
Overall survival (OS)
Time from SIRT procedure until death from any cause
Measured: 30 months
Tumor response in the liver
Response as per routine practice following the guidelines for corresponding tumor type
Measured: 3 months
Lung shunt prediction
Lung shunt prediction will be evaluated by comparing the predicted and actual lung shunt, either in terms of percentage or absorbed dose
Measured: 1 month
Secondary outcomes (7)
Administered activity
The technical performance of SIRT in term of administered activity in Becquerel (GBq or MBq) with QuiremSpheresTM Holmium-166 Microspheres.
Measured: 1 month
Liver volume treated
The technical performance of SIRT in term of liver volume treated in mL with QuiremSpheresTM Holmium-166 Microspheres.
Measured: 1 month
SIRT treatment approach
The technical performance of SIRT in term of treatment approach (selective, lobar, bi-lobar, whole liver) with QuiremSpheresTM Holmium-166 Microspheres.
Measured: 1 month
Tumor absorbed dose
The technical performance of SIRT in term of tumor absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.
Measured: 1 month
Normal liver absorbed dose
The technical performance of SIRT in term of normal liver absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.
Measured: 1 month
The use of Q-SuiteTM in clinical practice
The use of Q-SuiteTM in clinical practice will be recorded based on the software which is mentioned in the description of treatment or the presence of a Q-SuiteTM generated report in the patient's medical file.
Measured: 1 month
Number of patients downstaged to liver resection or liver transplantation
The number of patients downstaged to liver resection or liver transplantation will be reviewed based on the number of patients that underwent liver resection or liver transplantation after the SIRT procedure
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start17 Jan 2022
- Primary completion15 Feb 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111795
- Sponsor's protocol ID
- T141E4
- Acronym
- RECORD
- Status last verified
- Aug 2022
- First submitted
- 12 Oct 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium-166 Retrospective Collection of Real-World Data
- ClinicalTrials.gov ID
- NCT05111795
- Acronym / sponsor ID
- RECORD / T141E4
- Conditions
- Hepatocellular Carcinoma, Metastatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- 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.
The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.
Detailed description
This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be included has been treated at the top-ordering hospitals for QuiremSpheresTM Holmium-166 Microspheres. All patients treated at these hospitals between 15 July 2019 and 15 July 2021 are aimed to be included.
Key inclusion criteria (4 listed)
- Patient with diagnosis of primary liver tumor or metastases in the liver.
- Patients treated with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres from 15 July 2019 to 15 July 2021.
- Patient is ≥ 18 years.
- If required by national regulation, patient has understood and signed written informed consent to retrospective data collection.
Key exclusion criteria (1 listed)
- Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.
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 |
|---|---|---|
| Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 MicrospheresAlso: SIRT, Radioembolization, TARESIRT work-up procedure and SIRT procedure | Device | – |
Primary outcome
Frequency and Severity of Adverse Events
Time frame: 30 months
The primary safety endpoint is defined in terms of incidence of adverse events CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 3, or any grade of a predefined list of events stemming from risk management of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres.
Progression Free Survival (PFS)
Time frame: 30 months
Time from SIRT procedure until overall progression or death
Hepatic Progression Free Survival (HPFS)
Time frame: 30 months
Time from SIRT procedure until progression in the liver or death
Overall survival (OS)
Time frame: 30 months
Time from SIRT procedure until death from any cause
Tumor response in the liver
Time frame: 3 months
Response as per routine practice following the guidelines for corresponding tumor type
Lung shunt prediction
Time frame: 1 month
Lung shunt prediction will be evaluated by comparing the predicted and actual lung shunt, either in terms of percentage or absorbed dose
7 secondary outcomes
Administered activity
Time frame: 1 month
Liver volume treated
Time frame: 1 month
SIRT treatment approach
Time frame: 1 month
Tumor absorbed dose
Time frame: 1 month
Normal liver absorbed dose
Time frame: 1 month
The use of Q-SuiteTM in clinical practice
Time frame: 1 month
Number of patients downstaged to liver resection or liver transplantation
Time frame: 30 months
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 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Metastatic Cancer, run by Terumo Europe N.V. at 12 sites in 7 countries.
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 4 inclusion and 1 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Belgium, Italy, Netherlands, Portugal and 2 more countries. 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?
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?
Frequency and Severity of Adverse Events (time frame: 30 months). The study lists 6 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 30 Aug 2022.