RecruitingNot ApplicableNCT07365527

Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases

Tumor Response to Sonoporation: A Clinical Translational RCT of Contrast-enhanced Ultrasound Induced Changes in Tumor Microenvironment of Colorectal Liver Metastases

Sponsor

Zealand University Hospital

Enrollment

48 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

Liver Metastases From Colorectal Cancer

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether sonoporation — using ultrasound and tiny gas-filled bubbles to temporarily open up cancer cell membranes — can help chemotherapy drugs penetrate liver tumors more effectively in people with colorectal cancer that has spread to the liver. **You may be eligible if...** - You are 18 or older - You have confirmed colorectal cancer that has spread to the liver - You are scheduled for liver surgery or ablation, or are receiving chemotherapy for liver metastases - You have at least one liver metastasis visible on ultrasound - You are in adequate overall health (ECOG 0–2) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have serious heart, liver, or kidney problems - You have a known contrast allergy if contrast is required - You are unable to provide written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLow-intensity contrast enhanced ultrasound

The LI-CEUS arm will receive a 30-minute contrast-enhanced ultrasound session targeting a designated study metastasis. During the procedure, 1 mL of the ultrasound contrast agent SonoVue will be administered every 3 minutes throughout the entire session. Minimum 7 days after the intervention a biopsy of the study metastasis will be conducted.

OTHERHigh-intensity contrast enhanced ultrasound

The HI-CEUS intervention group will recieve a 30-minute CEUS procedure targeting a designated study metastasis. During the procedure, 1 mL of the ultrasound contrast agent SonoVue will be administered every 3 minutes throughout the entire session. A high-intensity ultrasound "flash" will be applied every 30 seconds. This "flash" consists of a brief sequence of ultrasound waves with a high mechanical index that causes complete destruction of microbubbles within the imaging field. Minimum 7 days after the intervention a biopsy of the study metastasis will be conducted.

Locations(2)

Rigshospitalet

Copenhagen, Denmark

Surgical Department, Zealand University Hospital

Køge, Denmark

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NCT07365527

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