Needle-based treatment for liver tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of INT001, a needle-based treatment for liver tumors, administered in an outpatient setting. Participants will receive INT001 under real-time image guidance, allowing for precise targeting of the tumor. The study will monitor the tumor's response to treatment and any medical issues that arise during the process through follow-up visits and imaging tests. The trial seeks to determine if INT001 can completely ablate liver tumors in adults who are not candidates for surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Koc University Hospital
  Topkapı, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Fatih Selcukbiricik, MD — Koc University Hospital
• Study coordinator: Rahmi Oklu, MD, PhD
• Email: roklu@intumotherapeutics.com
• Phone: +90 850-250-8250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.