NCT04491929Recruiting
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 27 Jul 2020
- Start date
- 1 Nov 2020
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT04491929
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Nov 2020 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Current or previously evidence of ascites on CT-scan or physical examination
Other illness
- Symptomatic lung disease precluding SIRT at interventionist´s decision
- Active uncontrolled infection
- Conditions precluding translational samples
Lab values
- 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
- 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)
Other
- Pregnancy
- Tumour volume greater than 50% of liver volume
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.