Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INT001 Treatment | Experimental | Patients with liver tumors enrolled in the study will receive INT001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle based delivery of INT001 into liver tumors under real-time image guidance | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation | Ablation of the tumor will be assessed using imaging criteria such as RECIST. | MRI will be performed the day of the intervention, at 30 days and at 90 days. |
| Adverse events | Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period | From day 1 to day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | Biomarkers such as AFP will be monitored | Day 30 and Day 90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rahmi Oklu, MD, PhD | Contact | +90 850-250-8250 | roklu@intumotherapeutics.com | |
| Erhan Bayburtluoglu, BS | Contact | +90 850-250-8250 | ctu@kuh.ku.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Fatih Selcukbiricik, MD | Koc University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koc University Hospital | Recruiting | Topkapı | Istanbul | 34010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38305472 | Result | 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. | |
| 38678378 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Prospective, Single-Arm, Open-label, Single-Center Clinical Study
Not provided
Not provided
Not provided
Not provided
|
|
| 38959326 | Result | 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. |
| 39148179 | Result | 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. |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |