Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT06689670

Needle-based Percutaneous Ablation of Liver Tumors.

Led by inTumo Therapeutics, Inc. · Updated on 2026-01-20

31

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Needle-based Percutaneous Ablation of Liver Tumors.

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of primary or secondary liver cancer
  • ECOG Performance Status score of 0 - 2
  • Age 18 years or older and under 100 years
  • Life expectancy of 3 months or more
  • Unsuitable for surgical resection or transplantation
  • Ability to understand and sign informed consent
  • Willingness and ability to follow study procedures and visits
Not Eligible

You will not qualify if you...

  • Decompensated liver function (Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis)
  • Liver dysfunction signs: AST or ALT more than 5 times upper limit of normal, bilirubin level over 2.0 mg/dL
  • Bleeding disorders
  • Allergy or intolerance to contrast agents used in imaging
  • Life-threatening serious extrahepatic disease
  • Conditions preventing benefit or safety such as ongoing infection, renal dysfunction, or morbidity
  • Significant medical or psychiatric illness
  • Pregnant or breastfeeding or planning pregnancy within 6 months
  • Participation in another study affecting treatment outcome
  • Lesions without contrast uptake on CT or MR angiography
  • Lesions not hypervascular on angiography
  • Lack of CT or MR imaging at screening or inability/unwillingness to undergo MRI during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Koc University Hospital

Topkapı, Istanbul, Turkey (Türkiye), 34010

Actively Recruiting

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Research Team

R

Rahmi Oklu, MD, PhD

CONTACT

E

Erhan Bayburtluoglu, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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