Pressure-enabled Delivery in Radioembolization (TriNav Study)
United States20 participantsStarted 2022-03-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 \<18 years of age with respect to tumor dosimetry and associated adverse events participants \<18 years of age, children are excluded from this study.
* ECOG performance status \< 2 (Karnofsky ≥60%, see Appendix A).
* Life expectancy \>16 weeks.
* Suitable target artery diameter(s), defined in the TriNav labelling as 1.5 to 3.5mm vessels, based upon pre-procedural imaging.
* Adequate organ and marrow function as defined below:
* International Normalized Ratio (INR): ≤ 1.5
* Hemoglobin: ≥ 8.5 g/dL
* Leukocytes: ≥2,000/mcL
* Absolute neutrophil count: ≥1,00/mcL
* Platelets: ≥50,000/mcL(after transfusion, if necessary)
* Total bilirubin: ≤2.0 mg/dL
* Albumin: ≥3 g/dL
* AST(SGOT)/ALT(SGPT): ≤6 × institutional ULN
* Glomerular filtration rate (GFR): 30 mL/min/1.73 m2
* Child Pugh Score A, or B7 with bilirubin ≤ 2 mg/dL.
* If extrahepatic disease is present (e.g. brain metastases), such disease must be stab…