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Needle-based Percutaneous Ablation of Liver Tumors.
Sponsor: inTumo Therapeutics, Inc.
Summary
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.
Official title: To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: A Prospective, Single-arm, Single-center Clinical Study
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2024-10-28
Completion Date
2027-12
Last Updated
2026-01-20
Healthy Volunteers
No
Interventions
Needle based delivery of INT001 into liver tumors under real-time image guidance
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.
Locations (1)
Koc University Hospital
Topkapı, Istanbul, Turkey (Türkiye)