Contrast-enhanced ultrasound to target liver metastases from colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, investigator-initiated, prospective randomized trial will allocate eligible patients with colorectal liver metastases to receive either low-intensity or high-intensity contrast-enhanced ultrasound (CEUS) focused on a single designated metastasis. Procedures will be performed at participating Danish centers, and safety, feasibility, and intervention success rates will be recorded. At least seven days after CEUS, a biopsy of the treated metastasis will be obtained and analyzed for immune cell infiltration, immune-related gene expression, and stromal and vascular changes. Results from the two randomized arms will be compared against a matched historical control group to determine whether CEUS exposure shifts the tumor microenvironment toward greater immune activity.

Why it matters

Who can join: the full rules

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

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Surgical Department, Zealand University Hospital
  Køge, Denmark Recruiting

Study contacts

• Principal investigator: Christian P Nolsøe, Professor — Center of Surgical Ultrasound, Surgical department of Zealand University Hospital
• Study coordinator: Maja M Jeppesen, M.D
• Email: mjepp@regionsjaelland.dk
• Phone: +45 47323011

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.