Needle-based treatment for liver tumors
To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: A Prospective, Single-arm, Single-center Clinical Study
This study is testing a new needle treatment for liver tumors to see if it can completely destroy the tumors in adults who can't have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | inTumo Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Topkapı, Istanbul) |
| Trial ID | NCT06689670 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary or secondary liver cancer who are unsuitable for surgical resection or transplantation.
Not a fit: Patients with severe liver dysfunction, bleeding disorders, or life-threatening extrahepatic diseases may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with liver tumors, potentially improving outcomes and quality of life.
How similar studies have performed: While the approach of needle-based ablation is established, the specific use of INT001 in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Topkapı, Istanbul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.