Status:
NOT_YET_RECRUITING
Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Soft Tissue Sarcomas
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief Summary
This is a single center, single arm phase I clinical trial exploring the feasibility and safety of performing transarterial embolization of incurable hypervascular pediatric soft tissue sarcomas with ...
Detailed Description
The study will include a screening period in which patient eligibility is determined. Once enrolled parents and patients over 5 years of age will complete a quality-of-life survey PedsQL with a dedica...
Eligibility Criteria
Inclusion
- Pediatric patient aged 2-18 years, weighing at least 20 kg
- Diagnosed with biopsy proven primary or metastatic soft tissue sarcoma designated as a non-curative surgical candidate and/or failure of standard of care chemotherapy/immunotherapy with local progression on 3-month post induction imaging
- Staging CT or MRI demonstrating at least 50% arterial vascularity by volume within at least one tumor measuring at least 3 cm in longest dimension with an identifiable arterial feeder within one month of screening visit
Exclusion
- Negative pregnancy test within 48 hours of angiography or lactation for females of childbearing age
- Known anaphylactic allergic reactions to iodinated contrast
- Planned surgery or radiation to the target site within the study period at time of enrollment
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07136571
Start Date
February 1 2026
End Date
February 1 2028
Last Update
August 22 2025
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35233