The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are: 1. Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate/kill the tumor entirely? 2. What medical problems do participants experience when receiving INT001? Participants will: Receive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Using ultrasound or CT imaging, the liver tumor is located. Under local anesthesia or, if necessary, intravenous sedation, the needle is inserted through the skin and the needle tip is brought to the center of the liver tumor using image guidance. 1-2 ml of the INT-001 is injected. The needle is removed and a bandaid is applied to the skin entry site. Right after, or as soon as MRI becomes available, MRI is performed to show that the entire tumor has been treated.
Koc University Hospital
Topkapı, Istanbul, Turkey (Türkiye)
RECRUITINGAblation
Ablation of the tumor will be assessed using imaging criteria such as RECIST.
Time frame: MRI will be performed the day of the intervention, at 30 days and at 90 days.
Adverse events
Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period
Time frame: From day 1 to day 90
Biomarkers
Biomarkers such as AFP will be monitored
Time frame: Day 30 and Day 90
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