Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Low-intensity contrast enhanced ultrasound
- High-intensity contrast enhanced ultrasound
Treatment groups
48 Participants
are divided into 3 treatment groupsSponsors and collaborators
Zealand University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov