Transarterial RadioembolizationTACOMENCT06030232
Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver
An observational study of Transarterial Radioembolization, run by Ankara University at 8 sites in Turkey (Türkiye).
Trial summary
Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transarterial Radioembolization
- What is being tested?
- Therasphere
- Type of treatment
- Medical device
- How many people
- 202 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Apr 2024
- 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: Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass microspheres in lobar or segmental fashion
Who may be able to join
- over 18 years old
- histopathologically proven colorectal cancer diagnosis
- treated with radioembolization for liver metastases with Y90 glass microspheres in lobar or segmental fashion
- have follow-up data at least 6 months after radioembolization
Who cannot join
- no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.
- No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Turkey (Türkiye)8 sites
Cukurova University Medical School
Adana
Ankara University Medical School
Ankara
Hacettepe Univeristy Medical School
Ankara
Istanbul University Capa Medical School
Istanbul
Istanbul University Cerrahpasa Medical School
Istanbul
Marmara University Medical School
Istanbul
Yeditepe University Medical School
Istanbul
Dokuz Eylul University Medical School
Izmir
About this study
Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.
Primary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.
- Conditions
- Transarterial Radioembolization
- Being tested
- Therasphere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherasphereDevice
Transarterial radioembolization
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Patients who received radioembolization for colorectal cancer liver metastases Receives: Device: Therasphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective tumor dose and safe healthy liver dose
Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.
Measured: 3th month after treatment
Secondary outcomes (1)
dose (in Gy) -response and dose (in Gy)-toxicity relationships
Investigate dose-response and dose-toxicity relationships after transarterial radioembolization.
Measured: 6th month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Jan 2024
- Primary completion15 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transarterial RadioembolizationStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Cigdem Soydal, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030232
- Sponsor's protocol ID
- TACOME-TR
- Acronym
- TACOME
- Status last verified
- Apr 2024
- First submitted
- 31 Aug 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver
- ClinicalTrials.gov ID
- NCT06030232
- Acronym / sponsor ID
- TACOME / TACOME-TR
- Conditions
- Transarterial Radioembolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 8 Sep 2023 (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.
Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.
Primary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Device: TheraspherePatients who received radioembolization for colorectal cancer liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass microspheres in lobar or segmental fashion
Key inclusion criteria (4 listed)
- over 18 years old
- histopathologically proven colorectal cancer diagnosis
- treated with radioembolization for liver metastases with Y90 glass microspheres in lobar or segmental fashion
- have follow-up data at least 6 months after radioembolization
Key exclusion criteria (2 listed)
- no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.
- No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver
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 |
|---|---|---|
| TherasphereTransarterial radioembolization | Device | Observation group |
Primary outcome
effective tumor dose and safe healthy liver dose
Time frame: 3th month after treatment
Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.
1 secondary outcome
dose (in Gy) -response and dose (in Gy)-toxicity relationships
Time frame: 6th month after treatment
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 24 Apr 2024.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transarterial Radioembolization, run by Ankara University at 8 sites in Turkey (Türkiye).
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 2 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye). 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?
effective tumor dose and safe healthy liver dose (time frame: 3th month after treatment). 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 24 Apr 2024.