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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT05361551
Eligibility Criteria:
Inclusion Criteria:
1. Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
2. Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
3. Distance to central bile ducts \> 1 cm;
4. Adequate glomerular filtration rate (GFR \> 40) and no severe allergies to iodine contrast-media;
5. Ability to understand and the willingness to sign written informed consent;
6. Age \> 18 years-old;
7. Performance status 0-2 (Eastern Cooperative Oncology Group Classification \[ECOG\]);
8. Expected survival \> 12 months.
Exclusion Criteria:
1. Use of other prior or concomitant local therapy at the target tumor(s).
2. Active bacterial infection or fungal infection on the day of the ablation.
3. Platelet \< 50,000/mm3.
4. INR \> 1.5
5. Patients with uncorrectable coagulopathy.
6. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
7. Physical or psychological condition which would impair study participation.
8. ASA (American Society of Anesthesiologists) score of ≥ 4.
9. Any other loco-regional therapies at the target lesion(s).
10. Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05361551
Study Brief:
Protocol Section:
NCT05361551