Liver Metastasis Colon CancerSIRTNCT04491929
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases
An observational study of Liver Metastasis Colon Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis Colon Cancer
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 study population consists of patients with metastatic colorectal cancer with chemorefractory liver dominant disease. Patients are found not eligible for surgical resection, RFA or SBRT by a multidisciplinary tumour board (MDT), and considered candidates for SIRT treatment in order to obtain disease control or resectability.
Who may be able to join
- Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease
- Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- The Liver metastasis are not eligible for resection, RFA or SBRT
- All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment
- All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment
- Progressive disease, severe intolerance during or following all standard lines of chemo-therapy
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Age 18 years or older
- Able to understand written information
- Consent to samples for translational research
Who cannot join
- Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract
- Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition
- Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with dose to the liver at interventionist´s decision
- Lung shunt greater than 20% or > 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA
- Pregnancy
- Symptomatic lung disease precluding SIRT at interventionist´s decision
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- Active uncontrolled infection
- Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and/or serum bilirubin greater than 2 mg/dl (>34 umol/l)
- Current or previously evidence of ascites on CT-scan or physical examination
- Tumour volume greater than 50% of liver volume
- Conditions precluding translational samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology, Aarhus University Hospital
Aarhus N, Danmark, 8200
Louise B Callesen, MD, 30482884, louicall@rm.dk
About this study
Official title: Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study
Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.
Read the detailed description
In this study, the investigators seek to investigate biological aspects in patients with colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation Therapy, by translational analysis of biological samples.
SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational blood samples will be drawn pre-treatment and during follow up.
The total cell free DNA level will be quantified in all samples. The samples will be analysed for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.
The investigators expect to include up to 30 patients.
This is a purely observational translational study. Results will be analysed in relation to outcome data.
The study is conducted in collaboration with:
Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University Hospital
- Conditions
- Liver Metastasis Colon Cancer
- Keywords
- Liver metastasis Colon Cancer, Circulating Tumour DNA, Selective Internal Radiation Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and translational analysis
Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis
Measured: When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.
Secondary outcomes (3)
Response Rate
According to RECIST 1.1
Measured: 6 months
Progression Free Survival
Measured: 3 years
Overall Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Nov 2020
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastasis Colon CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Bach Callesen, Aarhus University Hospital
- Investigators
- Louise B Callesen, Principal investigator, Experimental Clinical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491929
- Sponsor's protocol ID
- 1-10-72-111-20
- Acronym
- SIRT
- Status last verified
- Jan 2026
- First submitted
- 27 Jul 2020
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study
- ClinicalTrials.gov ID
- NCT04491929
- Acronym / sponsor ID
- SIRT / 1-10-72-111-20
- Conditions
- Liver Metastasis Colon Cancer
- Keywords
- Liver metastasis Colon Cancer, Circulating Tumour DNA, Selective Internal Radiation Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 30 Jul 2020 (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.
Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.
Detailed description
In this study, the investigators seek to investigate biological aspects in patients with colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation Therapy, by translational analysis of biological samples.
SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational blood samples will be drawn pre-treatment and during follow up.
The total cell free DNA level will be quantified in all samples. The samples will be analysed for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.
The investigators expect to include up to 30 patients.
This is a purely observational translational study. Results will be analysed in relation to outcome data.
The study is conducted in collaboration with:
Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University Hospital
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with metastatic colorectal cancer with chemorefractory liver dominant disease. Patients are found not eligible for surgical resection, RFA or SBRT by a multidisciplinary tumour board (MDT), and considered candidates for SIRT treatment in order to obtain disease control or resectability.
Key inclusion criteria (10 listed)
- Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease
- Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- The Liver metastasis are not eligible for resection, RFA or SBRT
- All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment
- All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment
Key exclusion criteria (11 listed)
- Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract
- Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition
- Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with dose to the liver at interventionist´s decision
- Lung shunt greater than 20% or > 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility and translational analysis
Time frame: When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.
Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis
3 secondary outcomes
Response Rate
Time frame: 6 months
Progression Free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- 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.
Louise B Callesen principal investigator
Experimental Clinical Oncology
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 Liver Metastasis Colon Cancer, run by Aarhus University Hospital at 1 site in Denmark.
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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise B Callesen, MD (+4578462535, louicall@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and translational analysis (time frame: When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.). 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 13 Jan 2026.