Needle-based Percutaneous Ablation of Liver Tumors.

January 15, 2026 updated by: inTumo Therapeutics, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Erhan Bayburtluoglu, BS
  • Phone Number: +90 850-250-8250
  • Email: ctu@kuh.ku.edu.tr

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Topkapı, Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Koc University Hospital
        • Contact:
        • Sub-Investigator:
          • Barbarol Cil, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of primary or secondary liver cancer.
  2. ECOG Performance Status score of 0 - 2
  3. Age ≥18 years, <100 years
  4. Life expectancy of ≥3 months
  5. Patient is unsuitable for surgical resection or transplantation
  6. Ability of the patient to understand and sign the Informed Consent Form describing the study's nature
  7. Volunteer's willingness and ability to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits

Exclusion Criteria:

  1. Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.
  2. Signs of liver dysfunction: AST or ALT >5 times the upper limit of normal (ULN), Serum bilirubin level >2.0 mg/dL
  3. Individuals with bleeding disorders.
  4. History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.
  5. Patients with life-threatening serious extrahepatic disease.
  6. Patients with concurrent conditions that, in the investigator's opinion, would prevent clinical benefit from the study procedure or could compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, or morbidity).
  7. Significant medical or psychiatric illness.
  8. Pregnant or breastfeeding women or women planning to conceive within the next 6 months.
  9. Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome.
  10. Lesions that do not show contrast uptake on contrast-enhanced CT or MR angiography.
  11. Lesions that are not hypervascular on angiography.
  12. Patients who do not have CT or MR imaging available at the screening visit or are unwilling or unable to undergo MRI for various reasons during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INT001 Treatment
Patients with liver tumors enrolled in the study will receive INT001
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.
Other Names:
  • Percutaneous tumor ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
MRI will be performed the day of the intervention, at 30 days and at 90 days.
Adverse events
Time Frame: From day 1 to day 90
Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period
From day 1 to day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers
Time Frame: Day 30 and Day 90
Biomarkers such as AFP will be monitored
Day 30 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

inTumo Therapeutics, Inc.

Investigators

  • Principal Investigator: Fatih Selcukbiricik, MD, Koc University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • inTumoThera

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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