Clinical trial · Interventional
Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases
Tumor Response to Sonoporation: A Clinical Translational RCT of Contrast-enhanced Ultrasound Induced Changes in Tumor Microenvironment of Colorectal Liver Metastases
NCT07365527CI-TRIAL-00104220CEUSONrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases From Colorectal Cancer | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-intensity contrast enhanced ultrasound | Other | — | UNRESOLVED |
| Low-intensity contrast enhanced ultrasound | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Historical control group
- description
- The historical control group consists of 24 matched patients who underwent liver resection for one or more colorectal liver metastases at Rigshospitalet between 2022 and the end of 2024. These patients serve as a non-intervention comparison cohort.
- type
- EXPERIMENTAL
- label
- Low-intensity CEUS intervention group
- description
- 12 eligible patients will be randomized to receive LI-CEUS intervention
- interventionNames
- Other: Low-intensity contrast enhanced ultrasound
- type
- EXPERIMENTAL
- label
- High-intensity CEUS intervention group
- description
- 12 eligible patients will be randomized to receive HI-CEUS intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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. * Known history of human immunodeficiency virus (HIV), active or chronic hepatitis B, or C. * Pregnancy or lactation. * Confirmed dMMR positive primary tumors * Inability to comply with study protocol due to psychological, social, or logistical reasons. * Contraindications for CEUS: * Known hypersensitivity to SonoVue® or any other ultrasound contrast agent * Uncontrolled atrial hypertension * Known right-to-left intracardiac shunt * Severe pulmonary hypertension (SAP \>90 mmHg) * Adult respiratory distress syndrome. * Known hypersensitivity to macrogols * Unstable ischemic heart disease or acute coronary syndrome * Severe lung disease, e.g. severe chronic obstructive lung disease
References
Publications (0)
Data not yet available
No reference posted for this study.