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

NCT ID: NCT07136571

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-02-29

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.

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 dedicated cancer module and visual analog scale questions for pain and procedural satisfaction. Approximately 2 weeks later the patient will undergo angiography and embolization where feasible. The patient will return for a post-procedural clinic visit at 2-weeks post intervention to assess for adverse effects and complete a follow up PedsQL and VAS surveys. If a major safety event is identified an independent reviewer will review all interim procedures to assess whether excess adverse events have occurred, and the study should be terminated. If this is exceeded the study will be aborted. The patient and parents will also complete PedsQL and VAS surveys in weeks 12- and 24-weeks post intervention. Follow up Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) concordant with baseline imaging modality will also be performed at weeks 12 and 24 to assess tumoral response.

Conditions

Soft Tissue Sarcomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pediatric soft tissue sarcoma group

Transarterial Embolization

Group Type: EXPERIMENTAL

bland particles

Intervention Type: DEVICE

embolization with bland particles of appropriate size

Interventions

bland particles

embolization with bland particles of appropriate size

Intervention Type: DEVICE

Other Intervention Names

Embozene Color-Advanced Microspheres

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Junaid Yasin Raja

Assistant Professor, Division of Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junaid Raja, MD, MSPH, FACP

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB

Birmingham, Alabama, United States

Countries

United States

Central Contacts

Evan Hudson

Role: CONTACT

evanhudson@uabmc.edu

205-934-6499

Facility Contacts

Evan Hudson

Role: primary

evanhudson@uabmc.edu

2059961082

Other Identifiers

Radiology Research Pilot Award

Identifier Type: OTHER

Identifier Source: secondary_id

R25-117

Identifier Type: -

Identifier Source: org_study_id