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Can a Pressure-Sensitive catheter sharpen Radiation's aim at liver tumors?

NCT ID NCT07791446

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a pressure-modulated catheter, called TriNav, delivers radiation more precisely to liver tumors than a standard catheter. People with liver metastases who are already scheduled for Y-90 radioembolization will have one tumor site treated with each catheter type. Researchers will compare the radiation dose reaching tumors and the response of tumors on scans at 3 and 6 months.

What this could mean

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

Active substance
TriNav Infusion System, a pressure-modulated microcatheter, compared with a standard end hole microcatheter for delivering Y-90 resin microspheres
What this could lead to
If the TriNav system delivers radiation more precisely to tumors, it could improve the effectiveness of Y-90 treatment for liver metastases while sparing healthy tissue.
What could go wrong
This is a small, early-stage trial, and the TriNav system may not improve radiation delivery or outcomes. There are also risks from the procedure itself, such as radiation damage to healthy liver tissue.

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 65 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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. Presence of multiple liver metastases 2. Prior multidisciplinary clinical decision for treatment with radioembolization 3. 18 years of age or older 4. ECOG less than or equal to 2 5. Life expectancy \> 3 months 6. Ability to understand and the willingness to provide written informed consent. 7. At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor 8. Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria 9. At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site. 10. Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm. 11. The vessel level for each planned delivery site is no further distal than the segmental level. Exclusion Criteria: 1. Pregnant 2. Breast-feeding 3. Lung shunt fraction \> 20% or calculated lung dose \> 30 Gy 4. Prior hepatic transarterial embolization in the hepatic lobe to be treated

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Liver metastases 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

  • Stanford University

    Palo Alto, California, 94305, United States

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