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New treatment option for Liver Tumors
Official title Needle-based Percutaneous Ablation of Liver Tumors.
ClinicalTrials.gov ID: NCT06689670
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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
You likely can't join if
- 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 how well it works 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...
See the full eligibility 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
- 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 how well it works 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Topkapı, Istanbul, Turkey (Türkiye)
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Topkapı, Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.