Needle-based Percutaneous Ablation of Liver Tumors.

Not Applicable

Recruiting

• Conditions: Liver Tumors; HCC - Hepatocellular Carcinoma; Metastatic Liver Tumor

• Registration Number: NCT06689670
• Lead Sponsor: inTumo Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
Safety	From day 1 to day 90	Adverse events, if any, will be recorded

Secondary Outcome Measures

Name	Time	Method
Biomarkers	Day 30 and Day 90	Biomarkers such as AFP will be monitored

Trial Locations

Locations (1)

Koc University Hospital; 🇹🇷 Topkapi, Istanbul, Turkey