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NCT05743842Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
19 (actual)
First submitted
15 Feb 2023
Start date
14 Mar 2023
Primary completion date
31 Dec 2027
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT05743842

What you commit to

  • Study type: Interventional
  • Participants enrolled: 19
  • From 14 Mar 2023 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.