Clinical trial · Interventional
Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study PI is leaving UAB and no longer opening study.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcomas | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bland particles | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pediatric soft tissue sarcoma group
- description
- Transarterial Embolization
- interventionNames
- Device: bland particles
Primary outcomes (1)
- measure
- 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
- description
- Safety will be evaluated by the number of patients with non-pain related major adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria. The study population to be explored no longer fits within a defined standard of care protocol. These patients unfortunately have a poor overall life expectancy and have not had a positive response to existing medication and radiation protocols. Transarterial embolization may offer a palliative treatment modality with potential benefit to patients in this cohort provided that it may be able to be performed successfully and safely. The minimal clinical acceptance performance standard for transarterial tumor embolization in the target population is 50% and will serve as the comparator for the primary outcome measure of percent of enrolled patients achieving technical procedural success.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available