Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas
NCT07136571 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2026-03-04
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 at least an index tumor with 50% arterial enhancement and a 3mm feeding vessel on pre study evaluation. The target study sample size is 10 tumors in a requisite number of participants. These patients will be enrolled to undergo evaluation of all angiographically visible tumors \>3cm with subsequent bland (not adsorbed to radioactive or chemotherapy) particle embolization of at least 25% perfusion to the target tumor.
Conditions
- Soft Tissue Sarcomas
Interventions
- DEVICE
-
bland particles
embolization with bland particles of appropriate size
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Junaid Raja, MD, MSPH, FACP · University of Alabama at Birmingham
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2028-02-29
- Completion
- 2028-02-29
- FDA Device
- Yes
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