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

NCT07136571 | Withdrawn FDA Device

• 2 other identifiers: R25-117Radiology Research Pilot Award
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Keywords

TRANSARTERIAL EMBOLIZATION; pediatric; soft tissue sarcoma; incurable

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  procedure/surgery

Secondary Outcomes (1)

• Local disease control will be assessed on 3- and 6-month staging MRI or CT scans using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

  Baseline to 6 months

Study Arms (1)

Pediatric soft tissue sarcoma group

EXPERIMENTAL

Transarterial Embolization

Device: bland particles

Interventions

bland particles DEVICE

embolization with bland particles of appropriate size

Also known as: Embozene Color-Advanced Microspheres

Pediatric soft tissue sarcoma group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Junaid Raja, MD, MSPH, FACP

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Interventional Radiology

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 22, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)