Actively Recruiting
Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases
Led by Zealand University Hospital · Updated on 2026-02-27
48
Participants Needed
2
Research Sites
46 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older)
- Ability to provide written informed consent
- Histopathologically confirmed colorectal adenocarcinoma
- Scheduled for liver resection or ablation at Rigshospital or receiving oncologic treatment for colorectal liver metastases at Zealand University Hospital
- Presence of at least one colorectal liver metastasis evaluable and accessible by contrast-enhanced ultrasound
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Women of childbearing potential must use secure and highly effective birth control during the trial
- Women not of childbearing potential defined as no menses for 12 months without medical cause or permanently sterile
You will not qualify if you...
- Oncologic systemic treatment within 2 weeks before inclusion
- Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-L1, anti-PD-1, anti-PD-L2)
- Inability to clearly distinguish the study metastasis from other liver metastases using contrast-enhanced ultrasound
- Systemic corticosteroid use (>10 mg daily prednisolone equivalents) or other immunosuppressive medications within 2 weeks prior to inclusion (inhaled or topical steroids allowed if no active autoimmune disease)
- Known HIV infection or active/chronic hepatitis B or C
- Pregnancy or lactation
- Confirmed mismatch repair deficient (dMMR) positive primary tumors
- Psychological, social, or logistical reasons preventing compliance with study protocol
- Contraindications to contrast-enhanced ultrasound, including hypersensitivity to SonoVue or other ultrasound contrast agents, uncontrolled atrial hypertension, right-to-left intracardiac shunt, severe pulmonary hypertension (SAP >90 mmHg), adult respiratory distress syndrome, hypersensitivity to macrogols, unstable ischemic heart disease or acute coronary syndrome, severe lung disease such as severe chronic obstructive pulmonary disease
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
2
Surgical Department, Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
Research Team
M
Maja M Jeppesen, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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