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Sound waves may wake up immune system against liver tumors

NCT ID NCT07365527

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using ultrasound with a contrast agent (sonoporation) can change the environment inside liver tumors that have spread from colorectal cancer. 48 adults will be randomly assigned to receive either low- or high-intensity ultrasound, or no ultrasound. The goal is to see if this procedure can make the tumor more welcoming to immune cells, potentially boosting future treatments.

What this could mean

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

Active substance
contrast-enhanced ultrasound (SonoVue)
What this could lead to
If it works, this could point toward a way to make liver tumors more responsive to the body's own immune system.
What could go wrong
This is a very early, small study (48 people) testing safety and biological effects, not treatment success. It may not lead to any direct benefit for patients.

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 48 people

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

Started

Feb 2026

Expected to finish

Jan 2027

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: * Adult patients (≥18 years) * Ability to provide written informed consent * Histopathological confirmed colorectal adenocarcinoma * Scheduled for liver resection or ablation at the Rigshospital, or admitted to oncologic treatment due to colorectal liver metastases (CLM) at Zealand University Hospital * Presence of at least one CLM evaluable and accessible by CEUS * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Follow the conditions regarding fertility, pregnancy, or lactation: * Women of childbearing potential (WOCBP) are defined as women ranging from the period of menarche till the post-menopausal period, unless permanently sterile (e.g. hysterectomy, bilateral salpingectomy and bilateral oophorectomy), Post-menopause is defined as no menses for 12 months without an alternative medical cause. * WOCBP should use a secure and highly effective birth control (as stated in the "Recommendations related to contraception and pregnancy testing in clinical trials", version 1.1, section 4.1, from the Clinical Trials Facilitation and Coordination Group) during the entire period of the trial. In cases of uncertainty regarding pregnancy, pregnancy testing either as highly sensitive serum or urine pregnancy test will be used. Exclusion Criteria: * Oncologic systemic treatment 2 weeks prior to inclusion * Prior treatment with an immune checkpoint inhibitor (e.g. anti-PD-L1, anti PD-1, or anti-PD-L2) * Inability to reliably distinguish the study metastasis from other hepatic metastases using CEUS * Systemic treatment with either corticosteroids (\>10 mg daily prednisolone equivalents) or other immunosuppressive medications within 2 weeks prior inclusion. Inhaled or topical steroids and adrenal replacements doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Known history of human immunodeficiency virus (HIV), active or chronic hepatitis B, or C. * Pregnancy or lactation. * Confirmed dMMR positive primary tumors * Inability to comply with study protocol due to psychological, social, or logistical reasons. * Contraindications for CEUS: * Known hypersensitivity to SonoVue® or any other ultrasound contrast agent * Uncontrolled atrial hypertension * Known right-to-left intracardiac shunt * Severe pulmonary hypertension (SAP \>90 mmHg) * Adult respiratory distress syndrome. * Known hypersensitivity to macrogols * Unstable ischemic heart disease or acute coronary syndrome * Severe lung disease, e.g. severe chronic obstructive lung disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Surgical Department, Zealand University Hospital

    RECRUITING

    Køge, 4600, Denmark

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