TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning

TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning

To learn if using the TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter.

Primary Objectives:

To determine the percentage of tumors that demonstrate quantitative mean dose concordance (within 20%) using voxel-level quantitative SPECT/CT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM (PEDDTM) device.

Secondary Objectives:

To determine the correlation of T:N ratios of all tumors 3cm based on 99mTc-MAA SPECT/CT and Y90 SPECT/CT imaging.

To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECT/CT.

To assess safety of TriNav catheter in this study population

Inclusion Criteria:

• Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent.
• Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, and must be non-pregnant with an acceptable contraception in premenopausal women.
• At least one lesion ≥ 3.0 cm in shortest dimension
• Negative pregnancy test in premenopausal women

Exclusion Criteria:

• Contraindications to angiography and selective visceral catheterization
• Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single injection.
• Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
• Infiltrative tumors
• Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm