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Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases

NCT07365527 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-02-27

No results posted yet for this study

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

Conditions

  • Liver Metastases From Colorectal Cancer

Interventions

OTHER

Low-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.

OTHER

High-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.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Christian P Nolsøe, Professor · Center of Surgical Ultrasound, Surgical department of Zealand University Hospital

  • Ismail Gögenur, Professor · Center of Surgical Science, Surgical department of Zealand University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2027-01-15
Completion
2027-01-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07365527 on ClinicalTrials.gov