Status:
UNKNOWN
Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization
Lead Sponsor:
UMC Utrecht
Conditions:
Colorectal Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of the SIM trial is to investigate whether using the Surefire Infusion System during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity concentration r...
Detailed Description
Study design: clinical within-subject randomized controlled trial. Study population: 25 patients with unresectable, chemorefractory, liver-dominant colorectal liver metastases. Intervention: scout a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- World health organization performance score \> 2
- Inadequate bone marrow function (hemoglobin \< 6.0 mmol/l, leukocyte count \< 3.0 x 109/l, platelet count \< 75x 109/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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02208804
Start Date
November 1 2014
Last Update
November 9 2016
Active Locations (1)
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1
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX