Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT06185556
Eligibility Criteria:
Inclusion Criteria:
* Histological documentation of primary colorectal tumor is available;
* 1-3 CRLM visible on ceCT and/or MRI, size 0-5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;
* Additional CRLM are allowed if considered either resectable or ablatable with a maximum of 10 CRLM. In patients with extrahepatic disease, a maximum of 5 additional CRLM is allowed;
* No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with some exclusions mentioned in the exclusion criteria);
* Prior focal liver treatment is allowed;
* Subjects should preferably be treated with neo-adjuvant systemic therapy;
* Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment who are unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable);
* Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to definite inclusion;
* ASA classification 0 - 3;
* Age \>18 years;
* Written informed consent;
Exclusion Criteria:
* Radical treatment unfeasible or unsafe (e.g. insufficient FLR);
* \>10 CRLM; \>5 CRLM when extra-hepatic disease is present;
* Positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis;
* Subjects who have progressive disease after neo-adjuvant systemic therapy;
* History of epilepsy;
* History of cardiac disease:
* Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
* Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites);
* Pregnant or breast-feeding subjects;
* Immunotherapy ≤ 2 weeks prior to the procedure;
* Chemotherapy and/or targeted therapy ≤ 2 weeks prior to the procedure;
* Severe allergy to contrast media not controlled with premedication;
* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06185556
Study Brief:
Protocol Section:
NCT06185556