Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases (NCT07365527) | Clinical Trial Compass
RecruitingNot Applicable
Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases
Denmark48 participantsStarted 2026-02-25
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clinical trials", version 1.1, section 4.1, from the Clinical Trials Facilitation and Coordination Group) during the entire period of the trial. In cases of uncertainty regarding pregnancy, pregnancy testing either as highly sensitive serum or urine pregnancy test will be used.
Exclusion Criteria:
* 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 th…
What they're measuring
1
Immune cell density (CD8+, CD3+) in colorectal liver metastases exposed to LI-CEUS or HI-CEUS, compared to controls.