Koc University Hospital
Topkapı, Istanbul, 34010, Turkey (Türkiye)
Location status: Recruiting
Location contact
Barbarol Cil, MD
SUB_INVESTIGATOR
Clinical Trials Unit CTU
CONTACT
NCT Number: NCT06689670
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Topkapı, Istanbul, 34010, Turkey (Türkiye)
Location status: Recruiting
Barbarol Cil, MD
SUB_INVESTIGATOR
Clinical Trials Unit CTU
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Percutaneous tumor ablation
Time frame: MRI will be performed the day of the intervention, at 30 days and at 90 days.
Ablation of the tumor will be assessed using imaging criteria such as RECIST.
Time frame: From day 1 to day 90
Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period
Time frame: Day 30 and Day 90
Biomarkers such as AFP will be monitored
Contact information is provided by the study sponsor or research team.
Erhan Bayburtluoglu, BS
CONTACT
Rahmi Oklu, MD, PhD
CONTACT
inTumo Therapeutics, Inc.
Industry
To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: A Prospective, Single-arm, Single-center Clinical Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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