Needle-based Percutaneous Ablation of Liver Tumors.
Turkey (Türkiye)31 participantsStarted 2024-10-28
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ablation
Timeframe: MRI will be performed the day of the intervention, at 30 days and at 90 days.
. 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.