Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization
NCT ID: NCT02208804
Last Updated: 2016-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
25 participants
INTERVENTIONAL
2014-11-30
Brief Summary
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Detailed Description
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Study population: 25 patients with unresectable, chemorefractory, liver-dominant colorectal liver metastases.
Intervention: scout and therapeutic doses of holmium-166 microspheres will be administered in the left and right hepatic artery during two sequential angiography procedures on the same day. In all subjects, the use of the Surefire Infusion System and the standard end-hole catheter will be randomly allocated to the infusion site (left and right hepatic artery).
Baseline and follow-up investigation: at baseline and during follow-up, patients will undergo physical examination and laboratory investigations for toxicity assessment, and a whole-body 18F-FDG-PET + dual-phase liver CT (at baseline and 3-months follow-up) for tumor response assessment. After the scout procedure and therapeutic procedure, a holmium-166 SPECT/CT will be obtained for the assessment of the microsphere distribution.
Main study parameters/endpoints:
The primary endpoint is the tumor to non-tumor activity concentration ratio on SPECT/CT.
Secondary endpoints include mean absorbed doses of radioactivity in tumorous and healthy liver tissue, tumor response, the predictive value of holmium-166 scout dose and infusion efficiency. These endpoints will be compared between the Surefire Infusion System and standard microcatheter infusions. A dose-response relationship, clinical toxicity and overall survival will be assessed for the entire cohort.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Surefire Infusion System
Hepatic arterial administrations using the Surefire Infusion System
Holmium-166-poly (L-lactic acid) microspheres
Standard End-hole Microcatheter
Hepatic arterial administrations using the standard end-hole microcatheter
Holmium-166-poly (L-lactic acid) microspheres
Interventions
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Holmium-166-poly (L-lactic acid) microspheres
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Maurice A.A.J. van den Bosch
Prof. dr.
Principal Investigators
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Maurice AAJ van den Bosch, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
UMCU Utrecht, The Netherlands
Max A Viergever, Prof. dr. ir.
Role: STUDY_DIRECTOR
UMC Utrecht, The Netherlands
Locations
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Department of Radiology and Nuclear Medicine, University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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References
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van Roekel C, van den Hoven AF, Bastiaannet R, Bruijnen RCG, Braat AJAT, de Keizer B, Lam MGEH, Smits MLJ. Use of an anti-reflux catheter to improve tumor targeting for holmium-166 radioembolization-a prospective, within-patient randomized study. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1658-1668. doi: 10.1007/s00259-020-05079-0. Epub 2020 Oct 31.
van den Hoven AF, Prince JF, Bruijnen RC, Verkooijen HM, Krijger GC, Lam MG, van den Bosch MA. Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial. Trials. 2016 Oct 25;17(1):520. doi: 10.1186/s13063-016-1643-3.
Other Identifiers
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14-287/D
Identifier Type: -
Identifier Source: org_study_id