Pressure-enabled delivery for liver tumors using TriNav: see how it changes tumor-to-normal liver contrast

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm study uses a pressure-enabled delivery device (TriNav Infusion System) during Y90 microsphere therapy to measure changes in CT-based tumor-to-normal liver ratio (TNR) from non-contrast to post-contrast imaging. It compares CT-derived enhancement with TNR from SPECT/CT mapping and assesses tumor dose, non-tumor liver dose, and microparticle load after treatment. Safety of the TriNav catheter in this context is also evaluated. Eligible participants are adults with unresectable liver tumors planned for partition dosimetry and bilateral, lobar, or sectoral Y90 delivery. The study is led by MD Anderson Cancer Center with TriSalus Life Sciences as a collaborator and involves a single-arm design to explore feasibility and correlations with imaging and dosimetry metrics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months
3. At least one lesion ≥ 3.0 cm in shortest dimension
4. Negative pregnancy test in premenopausal women with an acceptable contraception
5. Plan to perform bilobar, lobar or sectoral treatment using partition dosimetry
6. Evidence of partial or complete tumor vascularity based on pre-procedure liver protocol CT scan or MRI with contrast or intraprocedural hybrid angio CT as well as subjectively similar tumor vascularity between right and left lobes if bilobar treatment is planned
7. Right or left hepatic artery diameter of 1.5 mm to 5 mm (the recommended vessel size range for the TriNav Infusion System) based on pre-procedure arterial phase CT or intraprocedural hybrid angio CT

Exclusion Criteria:

1. Contraindications to angiography and selective visceral catheterization
2. Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single treatment session
3. CT based TNR of 3 or higher based on planning hybrid angioCT
4. 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)
5. Infiltrative tumors

Where it's running

• The University of Texas M. D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Peiman Habibollahi, MD — M.D. Anderson Cancer Center
• Study coordinator: Peiman Habibollahi, MD
• Email: phabibollahi@mdanderson.org
• Phone: (713) 792-4106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.