Clinical trial NCT06689670: Needle-based Percutaneous Ablation of Liver Tumors.
Official title: To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: a Prospective, Single-arm, Single-center Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Tumors
HCC - Hepatocellular Carcinoma
Metastatic Liver Tumor
Keywords: liver
tumor
ablation
needle
out-patient
Lead sponsor: inTumo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Single-Arm, Open-label, Single-Center Clinical Study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ablation
timeFrame: MRI will be performed the day of the intervention, at 30 days and at 90 days.
measure: Safety
timeFrame: From day 1 to day 90
Secondary outcomes:
measure: Biomarkers
timeFrame: Day 30 and Day 90
Other outcomes:
Locations:
city: Topkapi
country: Turkey
facility: Koc University Hospital
state: Istanbul
Study officials:
affiliation: Koc University Hospital
name: Fatih Selcukbiricik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keum H, Albadawi H, Zhang Z, Graf E, Santos PRD, Gunduz S, Oklu R. Bioengineered Ionic Liquid for Catheter-Directed Tissue Ablation, Drug Delivery, and Embolization. Adv Mater. 2024 Jun;36(23):e2309412. doi: 10.1002/adma.202309412. Epub 2024 Feb 16.
citation: Cevik E, Albadawi H, Zhang Z, Demirlenk Y, Atar D, Keum C, Kim J, Graf E, Gunduz S, Rehman S, Oklu R. Catheter-Directed Ionic Liquid Embolic Agent for Rapid Portal Vein Embolization, Segmentectomy, and Bile Duct Ablation. Adv Mater. 2024 Jul;36(29):e2402570. doi: 10.1002/adma.202402570. Epub 2024 May 7.
citation: Demirlenk YM, Albadawi H, Zhang Z, Atar D, Cevik E, Keum H, Kim J, Rehman S, Gunduz S, Graf E, Mayer JL, Dos Santos PR, Oklu R. Prostate tissue ablation and drug delivery by an image-guided injectable ionic liquid in ex vivo and in vivo models. Sci Transl Med. 2024 Jul 3;16(754):eadn7982. doi: 10.1126/scitranslmed.adn7982. Epub 2024 Jul 3.
citation: Albadawi H, Zhang Z, Keum H, Cevik E, Nagalo BM, Gunduz S, Kita H, Oklu R. Percutaneous Delivery of Oncogel for Targeted Liver Tumor Ablation and Controlled Release of Therapeutics. Adv Mater. 2024 Nov;36(45):e2406080. doi: 10.1002/adma.202406080. Epub 2024 Aug 15.