Sound waves may wake up immune system against liver tumors
NCT ID NCT07365527
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
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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
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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Surgical Department, Zealand University Hospital
RECRUITINGKøge, 4600, Denmark
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