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RecruitingNCT06689670Updated Jan 20, 2026

Needle-based Percutaneous Ablation of Liver Tumors.

An interventional study of Needle based delivery of INT001 into liver tumors under real-time image guidance in Liver Tumors, HCC - Hepatocellular Carcinoma and Metastatic Liver Tumor, sponsored by inTumo Therapeutics, Inc.. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by inTumo Therapeutics, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

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.

02

Conditions studied

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

Keywords

  • liver
  • tumor
  • ablation
  • needle
  • out-patient
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 31 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

inTumo Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceNeedle 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.

    Also known as: Percutaneous tumor ablation

06

What researchers measure

Primary outcomes

  1. Ablation

    Ablation of the tumor will be assessed using imaging criteria such as RECIST.

    Time frame: MRI will be performed the day of the intervention, at 30 days and at 90 days.

  2. Adverse events

    Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period

    Time frame: From day 1 to day 90

Secondary outcomes

  1. Biomarkers

    Biomarkers such as AFP will be monitored

    Time frame: Day 30 and Day 90

07

Study locations

1 of 1 sites recruiting
  • Koc University Hospital
    Topkapı, Istanbul 34010, Turkey (Türkiye)
    • Clinical Trials Unit CTU · Contact · ctu@kuh.ku.edu.tr · +90 850-250-8250
    • Barbarol Cil, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Keum H, Albadawi H, Zhang Z, Graf E, Santos PRD, Gunduz S, Oklu R. Bioengineered Ionic Liquid for Catheter-Directed Tissue Ablation, Drug Delivery, and Embolization. Adv Mater. 2024 Jun;36(23):e2309412. doi: 10.1002/adma.202309412. Epub 2024 Feb 16. PubMed 38305472 ↗
  • Cevik E, Albadawi H, Zhang Z, Demirlenk Y, Atar D, Keum C, Kim J, Graf E, Gunduz S, Rehman S, Oklu R. Catheter-Directed Ionic Liquid Embolic Agent for Rapid Portal Vein Embolization, Segmentectomy, and Bile Duct Ablation. Adv Mater. 2024 Jul;36(29):e2402570. doi: 10.1002/adma.202402570. Epub 2024 May 7. PubMed 38678378 ↗
  • Demirlenk YM, Albadawi H, Zhang Z, Atar D, Cevik E, Keum H, Kim J, Rehman S, Gunduz S, Graf E, Mayer JL, Dos Santos PR, Oklu R. Prostate tissue ablation and drug delivery by an image-guided injectable ionic liquid in ex vivo and in vivo models. Sci Transl Med. 2024 Jul 3;16(754):eadn7982. doi: 10.1126/scitranslmed.adn7982. Epub 2024 Jul 3. PubMed 38959326 ↗
  • Albadawi H, Zhang Z, Keum H, Cevik E, Nagalo BM, Gunduz S, Kita H, Oklu R. Percutaneous Delivery of Oncogel for Targeted Liver Tumor Ablation and Controlled Release of Therapeutics. Adv Mater. 2024 Nov;36(45):e2406080. doi: 10.1002/adma.202406080. Epub 2024 Aug 15. PubMed 39148179 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06689670
Lead sponsor
inTumo Therapeutics, Inc.
Responsible party
Sponsor
First posted
Nov 14, 2024
Start date
Oct 28, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 20, 2026

Study contacts

Rahmi Oklu, MD, PhD
Contact
roklu@intumotherapeutics.com
+90 850-250-8250
Erhan Bayburtluoglu, BS
Contact
ctu@kuh.ku.edu.tr
+90 850-250-8250
Fatih Selcukbiricik, MD
principal investigator · Koc University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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