Transarterial Embolization for Soft Tissue Sarcoma

EH
Overseen ByEvan Hudson
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and feasibility of transarterial embolization, a minimally invasive procedure, for children with certain types of soft tissue sarcomas. This method aims to reduce blood flow to tumors that cannot be surgically removed or have not responded to standard treatments, potentially helping to manage the condition. Eligible participants are children aged 2-18 years with a specific type of tumor that prior imaging has shown to have significant blood supply.

As an unphased trial, this study provides a unique opportunity for participants to contribute to pioneering research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transarterial embolization is safe for pediatric soft tissue sarcoma?

Research shows that transarterial embolization is usually well-tolerated in children with certain health issues. Studies have demonstrated that this treatment effectively stops bleeding during emergencies, with few serious side effects. Although this trial focuses on pediatric soft tissue sarcomas, similar procedures have proven safe in other cases. As this trial is in the early stages, the main goal is to ensure the treatment's safety for participants. Any unexpected side effects will be closely monitored.12345

Why are researchers excited about this trial?

Transarterial Embolization is unique because it offers a targeted approach to treating soft tissue sarcoma. Unlike traditional treatments like surgery, chemotherapy, or radiation, which can affect a large area of the body, this therapy delivers treatment directly to the tumor's blood supply. By blocking the blood vessels that feed the tumor, it aims to cut off the nutrients the tumor needs to grow. Researchers are excited about this technique because it has the potential to be less invasive and reduce the side effects compared to more systemic treatments.

What evidence suggests that transarterial embolization might be an effective treatment for soft tissue sarcoma?

Research has shown that transarterial embolization can effectively treat soft tissue sarcomas, which are cancers that start in the tissues connecting or supporting other body parts. This treatment cuts off the tumor's blood supply, helping to shrink it and slow its growth. In this trial, participants will receive transarterial embolization to assess its effectiveness in reducing symptoms and controlling tumors locally. Although often used with chemotherapy, researchers are exploring bland embolization (without drugs) for similar benefits. Previous studies have shown promising results in managing symptoms and controlling tumor growth in patients with similar conditions.678910

Who Is on the Research Team?

JR

Junaid Raja, MD, MSPH, FACP

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged 2-18 with incurable hypervascular soft tissue sarcomas. They must weigh at least 20 kg and have a tumor that's at least 3 cm with significant blood supply, not planned for surgery or radiation during the study, and no severe allergies to iodinated contrast.

Inclusion Criteria

I am between 2 and 18 years old and weigh at least 20 kg.
My scans show a tumor with significant blood supply, measuring 3 cm or larger.
My soft tissue sarcoma cannot be cured with surgery, and treatments like chemotherapy or immunotherapy have not stopped its growth.

Exclusion Criteria

I am scheduled for surgery or radiation on the cancer site during the study.
I have had a negative pregnancy test within the last 48 hours.
Known anaphylactic allergic reactions to iodinated contrast

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants undergo angiography and transarterial embolization of tumors

1 day
1 visit (in-person)

Post-procedural Follow-up

Participants return for a clinic visit to assess adverse effects and complete follow-up surveys

2 weeks post-intervention
1 visit (in-person)

Extended Follow-up

Participants complete PedsQL and VAS surveys and undergo imaging to assess tumoral response

24 weeks
2 visits (in-person) at weeks 12 and 24

What Are the Treatments Tested in This Trial?

Interventions

  • Transarterial Embolization
Trial Overview The trial tests transarterial embolization using bland particles on tumors larger than 3cm in children with advanced soft tissue sarcoma. It aims to assess the safety and feasibility of this procedure in up to 10 tumors across participants.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Pediatric soft tissue sarcoma groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Transarterial Embolization and Percutaneous Ablation of ...Both therapies have been shown to be safe and effective for reducing morbidity and local control of STTs, specifically in patients who are ...
Treatment options in unresectable soft tissue and bone ...Transarterial chemo-embolization can be used in locally unresectable STS, leading to a reduction in pain scores, promising local response rates ...
Full article: Feasibility and Tolerability of Arterial Infusion ...Despite incremental advances in systemic therapy, outcomes for advanced STS remained modest with typical median PFS of 4–6 months and limited response rates ...
Efficacy and Safety of Trans-Arterial Yttrium-90 ...Patients with primary and metastatic hepatic STS have a particularly poor prognosis, with a 2-year overall survival (OS) rate of 22% for the former and 21.7% ...
Treatment Outcome Following Transarterial ...A study showed that transarterial chemoembolization (TACE) was an effective treatment method for advanced STS, with 1-and 2-year OS rates of 71.5% and 45.8%. [6] ...
Phase I Study of Safety and Feasibility of Transarterial ...Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas ... Download Trial Data.
Transarterial Embolization for Soft Tissue SarcomaThis trial is for pediatric patients aged 2-18 with incurable hypervascular soft tissue sarcomas. They must weigh at least 20 kg and have a tumor that's at ...
Embolization in Pediatric Patients: A Comprehensive Review ...The clinical outcomes of embolization for acute arterial bleeding in trauma are excellent, with high rates of technical and clinical success and low rates of ...
Phase I Study of Safety and Feasibility of TransarterialThis is a single center, single arm phase I clinical trial exploring the feasibility and safety of performing transarterial embolization of incurable ...
Opportunities for interventional radiology in paediatric ...Treatment outcome following transarterial chemoembolization in advanced bone and soft tissue sarcomas. Cardiovasc. Interv. Radiol., 39 (2016), pp. 1420-1428 ...
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