Surefire Infusion system vs. standard Microcatheter use during holmium-166 radioembolization for the treatment of colorectal liver metastases.
- Conditions
- Colorectal cancer liver metastases10019815
- Registration Number
- NL-OMON47111
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
* Written informed consent.
* Histopathologically confirmed diagnosis of adenocarcinoma of the colon or rectum.
* Hepatic metastases with measurable morphological appearance (* 1 cm) on cross sectional imaging, located in the right and left hepatic arterial perfusion territory.
* Unresectable, liver dominant disease.
* Progressive disease after second line chemotherapy or no further chemotherapeutical treatment options due to severe side effects or unwillingness of the patient to undergo systemic chemotherapy.
* Age * 18 years.
* Expected adequacy of follow-up.
* WHO (World health organization) performance score > 2
* Inadequate bone marrow function (hemoglobin < 6.0 mmol/l, leukocyte count < 3.0 x 10^9/l, platelet count < 75x 10^9/l), inadequate liver function (bilirubin > 35 µmol/l, aspartate aminotransferase / alanine aminotransferase (AST/ALT) > 5 x upper limit of normal (ULN)) or inadequate renal function (creatinine > 1.5 x ULN).
* Prior hemihepatectomy.
* Compromised biliary system (biliary stent or hepaticojejunostomy).
* Child Pugh score B7 or worse.
* Active hepatitis B or C.
* Main portal vein thrombosis on CT (or previous portal vein embolization).
* Severe celiac axis stenosis on CT.
* Unsuitable hepatic arterial anatomy on CT.
* Treatment with systemic chemotherapy within 4 weeks prior to radioembolization.
* Previous participation in a study classified as class III by a radiation safety committee
* Bleeding diathesis.
* Pregnancy or breast feeding.
* Life expectancy < 3 months.
* Patients who are declared incompetent.
* Any condition that prevents from safe treatment with radioembolization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the T/N activity concentration ratio. The primary<br /><br>endpoint will be compared between the ARC and standard micocatheter infusions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include mean absorbed doses of radioactivity in tumorous<br /><br>and healthy liver tissue, infusion efficiency, the predictive value of<br /><br>166Ho-scout dose and tumor response. These enpoints will be compared between<br /><br>the ARC and standard micocatheter infusions. A dose-response relationship,<br /><br>clinical toxicity and overall survival will be assessed for the entire cohort.</p><br>