Needle-based Percutaneous Ablation of Liver Tumors.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorinTumo Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of primary or secondary liver cancer.
ECOG Performance Status score of 0 - 2
Age ≥18 years, <100 years
Life expectancy of ≥3 months
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Needle based delivery of INT001 into liver tumors under real-time image guidance
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov