NCT06689670Recruiting
Needle-based Percutaneous Ablation of Liver Tumors.
To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: A Prospective, Single-arm, Single-center Clinical Study
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 6 Nov 2024
- Start date
- 28 Oct 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- inTumo Therapeutics, Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06689670
What you commit to
- Study type: Interventional
- Planned participants: 31
- From 28 Oct 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome.
Other illness
- 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.
- Significant medical or psychiatric illness.
Lab values
- Signs of liver dysfunction: AST or ALT \>5 times the upper limit of normal (ULN), Serum bilirubin level \>2.0 mg/dL
Other
- Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.
- Pregnant or breastfeeding women or women planning to conceive within the next 6 months.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Koc University Hospital Coordinator of this site? Confirm its status | Topkapı | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.