Colorectal Neoplasms Clinical Trial
Official title:
Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization for the Treatment of Colorectal Liver Metastases (SIM Trial)
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 ratio, compared with using a standard end-hole microcatheter.
Study design: clinical within-subject randomized controlled trial.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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