HCC - Hepatocellular Carcinoma, Liver Tumors, Metastatic Liver Tumor
Conditions
Keywords
liver, tumor, ablation, needle, out-patient
Brief 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.
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.
Sponsors
inTumo Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Single-Arm, Open-label, Single-Center Clinical Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation | MRI will be performed the day of the intervention, at 30 days and at 90 days. | Ablation of the tumor will be assessed using imaging criteria such as RECIST. |
| Adverse events | From day 1 to day 90 | Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | Day 30 and Day 90 | Biomarkers such as AFP will be monitored |
Countries
Turkey (Türkiye)
Contacts
CONTACTRahmi Oklu, MD, PhD
CONTACTErhan Bayburtluoglu, BS
PRINCIPAL_INVESTIGATORFatih Selcukbiricik, MD
Koc University Hospital
Outcome results
None listed