Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * 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 c