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Recruiting

NCT Number: NCT06689670

Needle-based Percutaneous Ablation of Liver Tumors.

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koc University Hospital

Topkapı, Istanbul, 34010, Turkey (Türkiye)

Location status: Recruiting

Location contact

Barbarol Cil, MD

SUB_INVESTIGATOR

Clinical Trials Unit CTU

CONTACT

[email protected]

+90 850-250-8250

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.
  • Signs of liver dysfunction: AST or ALT >5 times the upper limit of normal (ULN), Serum bilirubin level >2.0 mg/dL
  • Individuals with bleeding disorders.
  • History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.
  • Patients with life-threatening serious extrahepatic disease.
  • 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).
  • Significant medical or psychiatric illness.
  • Pregnant or breastfeeding women or women planning to conceive within the next 6 months.
  • Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome.
  • Lesions that do not show contrast uptake on contrast-enhanced CT or MR angiography.
  • Lesions that are not hypervascular on angiography.
  • 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.

Treatment and study plan

Needle based delivery of INT001 into liver tumors under real-time image guidance

Device

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Biomarkers

    Time frame: Day 30 and Day 90

    Biomarkers such as AFP will be monitored

Study contacts

Contact information is provided by the study sponsor or research team.

Erhan Bayburtluoglu, BS

CONTACT

[email protected]

+90 850-250-8250

Rahmi Oklu, MD, PhD

CONTACT

[email protected]

+90 850-250-8250

Sponsors and collaborators

Lead sponsor

inTumo Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 14, 2024
Registry last updated
Jan 20, 2026

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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