NCT04491929 Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases
| NCT ID | NCT04491929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Liver Metastasis Colon Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2020-11-01 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Louise B Callesen
PRINCIPAL INVESTIGATOR
Experimental Clinical Oncology
Frequently Asked Questions
Who can join the NCT04491929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Metastasis Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04491929 currently recruiting?
Yes, NCT04491929 is actively recruiting participants. Contact the research team at louicall@rm.dk for enrollment information.
Where is the NCT04491929 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT04491929 clinical trial?
NCT04491929 is sponsored by Aarhus University Hospital. The principal investigator is Louise B Callesen at Experimental Clinical Oncology. The trial plans to enroll 30 participants.
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