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Needle-based Percutaneous Ablation of Liver Tumors.

NCT06689670 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Liver Tumors
  • HCC - Hepatocellular Carcinoma
  • Metastatic Liver Tumor

Interventions

DEVICE

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.

Sponsors & Collaborators

  • inTumo Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Fatih Selcukbiricik, MD · Koc University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06689670 on ClinicalTrials.gov