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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT02781935
Eligibility Criteria:
Inclusion Criteria for Eligibility:
1. Contrast-enhanced thorax, abdomen and pelvic CT scan (with at least portal venous phase for the liver) at diagnosis and right before surgery are available
2. Multiparametric MRI at baseline and right before surgery are available (T1/T2, DW-MRI and contrast enhanced MRI).
3. WHO performance status of 0 or 1
4. Previous treatments (chemotherapy, surgery) for primary, liver and extra-hepatic metastases are allowed.
5. No other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer gleason score ≤ 6, and basal/squamous cell carcinoma of the skin
6. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
Criteria for Enrollment
1. Conversion therapy is either being given or completed
2. Patient is suitable for hepatic resection based on the assessment of MDT composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery
3. Hepatic resection is scheduled to take place within 8 weeks of latest imaging
Exclusion Criteria:
1. Contraindications to any contrast agents for CT and MRI or MRI procedure
2. Pregnancy
3. Significant comorbidity that will preclude either conversion therapy or surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02781935
Study Brief:
Protocol Section:
NCT02781935