Soft Tissue SarcomasNCT07136571
Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas
A study testing bland particles in people with Soft Tissue Sarcomas, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Soft Tissue Sarcomas
- What is being tested?
- bland particles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- bland particles
- Keywords
- TRANSARTERIAL EMBOLIZATION, pediatric, soft tissue sarcoma, incurable
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bland particlesDevice
Also called Embozene Color-Advanced Microspheres
embolization with bland particles of appropriate size
| Study group | Role | What they receive |
|---|---|---|
| Pediatric soft tissue sarcoma group | Experimental | Transarterial Embolization Receives: Device: bland particles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Local disease control for these patients who otherwise do not have a standard of care protocol may offer palliation or potential survival benefit as has been seen in other, mostly adult, cancer patients.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Study PI is leaving UAB and no longer opening study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomasStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junaid Yasin Raja, University of Alabama at Birmingham
- Investigators
- Junaid Raja, MD, MSPH, FACP, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136571
- Sponsor's protocol ID
- IRB-300015394 R25-117
- Other IDs
- Radiology Research Pilot Award
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT07136571
- Acronym / sponsor ID
- IRB-300015394 R25-117
- Conditions
- Soft Tissue Sarcomas
- Keywords
- TRANSARTERIAL EMBOLIZATION, pediatric, soft tissue sarcoma, incurable
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study PI is leaving UAB and no longer opening study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric soft tissue sarcoma group | Experimental | Device: bland particlesTransarterial Embolization |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bland particlesAlso: Embozene Color-Advanced Microspheresembolization with bland particles of appropriate size | Device | Pediatric soft tissue sarcoma group |
Primary outcome
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.
Time frame: procedure/surgery
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.
1 secondary outcome
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.
Time frame: Baseline to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junaid Raja, MD, MSPH, FACP principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing bland particles in people with Soft Tissue Sarcomas, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.