WithdrawnNot Applicable

Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas

Stopped: Study PI is leaving UAB and no longer opening study.

0Started 2026-02

Plain-language 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.

Who can participate

Age range

2 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of technical success will be defined as proportion of enrolled patients that were able to undergo angioembolization of at least 25% of the target tumor by volume as determined by post-procedure cone beam CT imaging.

Timeframe: procedure/surgery

Trial details

NCT IDNCT07136571

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

View on ClinicalTrials.gov More Soft Tissue Sarcomas trials