NCT02208804|UnknownPhase 2/3
Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization
SIM
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SIM
Sponsor study identifier
interventional
25
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe 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 ratio, compared with using a standard end-hole microcatheter.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 31, 2014
Actual (reported)August 5, 2014
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT
5 days after treatment
Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT
5 days after treatment
Posttreatment tumor response on CT and 18F-FDG-PET
3 months after treatment
Predictive value of the holmium-166 scout dose
Hepatic arterial administrations using the Surefire Infusion System
Hepatic arterial administrations using the standard end-hole microcatheter
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
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.
Maurice AAJ van den Bosch, Prof. dr.
UMCU Utrecht, The Netherlands
Max A Viergever, Prof. dr. ir.
UMC Utrecht, The Netherlands
First Submitted
July 31, 2014
First Posted
August 5, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)
On the day of treatment
Dose-response relationship between tumor absorbed doses on SPECT/CT and tumor response on CT and 18F-FDG-PET
3 months after treatment
Infusion efficiency
On the day of treatment
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 9, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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