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

Running, not enrolling · Not applicable

Conditions studied: Liver Cancer

In brief

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.

Key facts

Study ID

NCT05743842

Run by

M.D. Anderson Cancer Center

People needed

19

Starts

2023-03-14

Expected to finish

2027-12-31

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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