Studies ultrasound with contrast in colorectal cancer that has spread to the liver
Tests contrast-enhanced ultrasound in adults with colorectal cancer spread to the liver.
Plain-language title generated from the registry record
Registry title: Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases
Key facts
- Where
- Copenhagen and Køge, DenmarkSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer that has spread to the liver. It tests ultrasound with a contrast agent to see how the tumor reacts.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Colorectal adenocarcinoma confirmed by tissue examination, with at least one liver metastasis that can be seen and reached by contrast ultrasound. Planned for liver surgery or ablation at Rigshospital, or in cancer treatment at Zealand University Hospital. Performance status (ECOG) of 0-2.
- Earlier treatment
- No cancer drug treatment in the 2 weeks before joining. No earlier immune checkpoint inhibitor (such as anti-PD-L1, anti-PD-1 or anti-PD-L2). No steroids above 10 mg daily prednisolone equivalents or other immune-suppressing drugs in the 2 weeks before joining.
- Biomarker or test result
- Primary tumors confirmed dMMR positive cannot join.
Main reasons for not taking part
- Known HIV, or active or chronic hepatitis B or C
- Pregnancy or breastfeeding
- Allergy to SonoVue or another ultrasound contrast agent, or to macrogols
- Heart or lung conditions that rule out contrast ultrasound, such as unstable ischemic heart disease or severe lung disease
- Study metastasis cannot be told apart from other liver metastases on contrast ultrasound
Read by machine on 9 November 2026.
Where in Denmark
- RigshospitaletCopenhagen, DenmarkTaking people
- Surgical Department, Zealand University HospitalKøge, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zealand University Hospital
- Trial code
- NCT07365527
- Record updated
- 27 February 2026
- Original description
This study is an investigator-initiated, randomized controlled trial enrolling patients with colorectal liver metastases. The objectives are to evaluate the safety and efficacy of contrast-enhanced ultrasound (CEUS)-mediated sonoporation as a potential therapeutic intervention and to investigate whether sonoporation can modulate the tumor microenvironment toward a more immune-active stateRead full original descriptionShow less
Tumor Response to Sonoporation: A Clinical Translational RCT of Contrast-enhanced Ultrasound Induced Changes in Tumor Microenvironment of Colorectal Liver Metastases
This study is an investigator-initiated, randomized controlled trial enrolling patients with colorectal liver metastases. The objectives are to evaluate the safety and efficacy of contrast-enhanced ultrasound (CEUS)-mediated sonoporation as a potential therapeutic intervention and to investigate whether sonoporation can modulate the tumor microenvironment toward a more immune-active state
Inclusion: 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: 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); 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; 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; Inability to reliably distinguish the study metastasis from other hepatic metastases using CEUS; Pregnancy or lactation; Confirmed dMMR positive primary tumors; Inability to comply with study protocol due to psychological, social, or logistical reasons.