End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.

Pressure-Enabled Selective SIR-Sphere Uptake for Radiation Efficacy (PRESSURE): A Prospective Randomized Clinical Trial of End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.

Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System.

A standard of care post-Y-90 PET/CT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST/mRECIST criteria.

Inclusion Criteria:

1. Presence of multiple liver metastases
2. Prior multidisciplinary clinical decision for treatment with radioembolization
3. 18 years of age or older
4. ECOG less than or equal to 2
5. Life expectancy > 3 months
6. Ability to understand and the willingness to provide written informed consent.
7. At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor
8. Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria
9. At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site.
10. Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm.
11. The vessel level for each planned delivery site is no further distal than the segmental level.

Exclusion Criteria:

1. Pregnant
2. Breast-feeding
3. Lung shunt fraction > 20% or calculated lung dose > 30 Gy
4. Prior hepatic transarterial embolization in the hepatic lobe to be treated