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New catheter aims to boost radiation to liver tumors while sparing healthy tissue

NCT ID NCT07444645

Knowledge-focused Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study tests whether a special catheter called TriNav can deliver more radiation beads (Y90 microspheres) to liver tumors while reducing exposure to healthy liver tissue. Twenty adults with unresectable liver tumors will receive the standard radioembolization procedure using both the TriNav and a standard catheter, and doctors will compare CT scans to see which delivers a better tumor-to-normal liver ratio. The goal is to see if the TriNav device can improve treatment precision without increasing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Y90 microsphere therapy (radioembolization)
What this could lead to
If successful, this could show that using the TriNav catheter delivers more radiation to liver tumors while sparing healthy liver tissue, potentially improving treatment outcomes.
What could go wrong
This is a very small, early-phase study (20 people) that only measures imaging changes, not survival or cure. The device may not work better than standard catheters, and there is a risk of side effects from the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

liver cancer liver disorder neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LIVER Tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas M. D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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