Status:
RECRUITING
Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Liver Ablation
Hepatic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT ...
Detailed Description
Primary Objective: To evaluate the technical efficacy and Local Tumor Progression-free survival \[LTPFS\] of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during he...
Eligibility Criteria
Inclusion
- Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
- Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
- Distance to central bile ducts \> 1 cm;
- Adequate glomerular filtration rate (GFR \> 40) and no severe allergies to iodine contrast-media;
- Ability to understand and the willingness to sign written informed consent;
- Age \> 18 years-old;
- Performance status 0-2 (Eastern Cooperative Oncology Group Classification \[ECOG\]);
- Expected survival \> 12 months.
Exclusion
- Use of other prior or concomitant local therapy at the target tumor(s).
- Active bacterial infection or fungal infection on the day of the ablation.
- Platelet \< 50,000/mm3.
- INR \> 1.5
- Patients with uncorrectable coagulopathy.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
- Physical or psychological condition which would impair study participation.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Any other loco-regional therapies at the target lesion(s).
- Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.
Key Trial Info
Start Date :
February 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05361551
Start Date
February 21 2023
End Date
August 31 2026
Last Update
October 14 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030