RecruitingNot ApplicableNCT06689670

Needle-based Percutaneous Ablation of Liver Tumors.

To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: A Prospective, Single-arm, Single-center Clinical Study

Sponsor

inTumo Therapeutics, Inc.

Enrollment

31 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

HCC - Hepatocellular Carcinoma Liver Tumors Metastatic Liver Tumor

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating needle-based percutaneous ablation — a procedure where a needle is inserted through the skin to destroy tumours in the liver using heat or cold energy — for people with primary or secondary liver cancer who cannot have surgery. **You may be eligible if...** - You are 18 or older (under 100) - You have primary liver cancer or cancer that has spread to the liver from elsewhere - You are not suitable for surgical removal of the tumour or liver transplant - Your general health is reasonable (ECOG 0–2) and life expectancy is at least 3 months **You may NOT be eligible if...** - You are a candidate for surgery or transplant - You have severe blood clotting problems or other conditions that make the procedure unsafe - You are unable to give informed consent or follow study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeedle 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)

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NCT06689670

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