Overview
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.
Description
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
Eligibility
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
