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Completed
NCT05128032
Pressure-enabled Delivery in Radioembolization (TriNav Study)
Conditions: Liver Cancer, Hepatocellular Carcinoma, Metastatic Colorectal Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 29
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Cancer Center Boston Massachusetts
Summary
The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer.
The name of the devices involved in this study are:
* Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System
* Standard 2.4F microcatheter, not otherwise specified
Eligibility Criteria
Inclusion Criteria:
* Known HCC or CLM that are not amenable to curative resection or thermal ablative techniques such as microwave ablation.
* Prior clinical decision for treatment by radioembolization.
* Disease that is visible on CT or MRI as well as measurable disease in the liver. Measurable is defined as at least one lesion in the expected treatment field that can be accurately measured in at least one dimension (longest diameter) as (≥1 cm) with CT scan or MRI.
* Age ≥18 years. Because there is limited data with respect to radioembolization in patients \
Source: ClinicalTrials.gov (NCT05128032). StuddyBuddy aggregates publicly available trial information.