To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: a Prospective, Single-arm, Single-center Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Diagnosis of primary or secondary liver cancer.

• ECOG Performance Status score of 0 - 2

• Age ≥18 years, \<100 years

• Life expectancy of ≥3 months

• Patient is unsuitable for surgical resection or transplantation

• Ability of the patient to understand and sign the Informed Consent Form describing the study's nature

• Volunteer's willingness and ability to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits

Locations
Other Locations
Turkey
Koc University Hospital
RECRUITING
Topkapı
Contact Information
Primary
Rahmi Oklu, MD, PhD
roklu@intumotherapeutics.com
+90 850-250-8250
Backup
Erhan Bayburtluoglu, BS
ctu@kuh.ku.edu.tr
+90 850-250-8250
Time Frame
Start Date: 2024-11
Estimated Completion Date: 2025-06
Participants
Target number of participants: 31
Treatments
Experimental: INT001 Treatment
Patients with liver tumors enrolled in the study will receive INT001
Related Therapeutic Areas
Sponsors
Leads: inTumo Therapeutics, Inc.

This content was sourced from clinicaltrials.gov