Arterial embolization for desmoid fibromatosis
Official title: Treatment of Desmoid Fibromatosis With Arterial Embolization: Retrospective and Prospective Observational Study
Run by Istituto Ortopedico Rizzoli · NCT06945887 · Data updated 2026-11-12
This trial tries blocking the tumor blood supply with embolic material (no chemotherapy) in people aged 12 and up who have symptomatic, actively growing desmoid fibromatosis and are not candidates for surgery or cryoablation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Drugs / interventions | chemotherapy, Doxorubicin |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | February 2028 |
| Study ends | February 2029 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT06945887 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 12 years or older with symptomatic, actively growing desmoid fibromatosis who are not eligible for surgery or cryoablation, can undergo MRI, and can provide informed consent.
✕Probably not a fit
Patients with non‑active (stable) desmoid disease, life expectancy under three months, severe coagulopathy, active infection, or those eligible for curative surgery/cryoablation are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational program collects outcomes from patients treated with arterial embolization using embolic material alone, without chemotherapy, including those treated since 01/01/2023 and newly scheduled patients. Participants undergo imaging (MRI or CT) and clinical follow-up to document tumor size change, symptom relief, and procedure-related complications. The approach builds on published retrospective and prospective reports of chemoembolization but tests a chemo-free embolization strategy that the investigators have reported positively for musculoskeletal tumors. Data will inform safety, local control, and symptom outcomes compared with historical results from other approaches.
Why it matters
Potential benefit: If successful, this approach could control tumor growth and reduce pain while avoiding the systemic toxicities associated with chemotherapy.
How similar studies have gone: Prior retrospective and prospective studies using chemoembolization have reported promising tumor control, while embolization without chemotherapy has been reported positively in series but is less extensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes aged ≥ 12 years * Fibromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups) * Patients not eligible for surgery or cryoablation * Patients who have had embolization surgery for fibromatosis desmoide from 01/01/2023 to date and all new patients listed for this type of treatment. * Signature of informed consent to the study Exclusion Criteria: * Patients with life expectancy \<3 months or severely impaired status functional status (ASA 4) * Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT) * Patients with coagulation deficiency or plateletopenic disease * Patients with documented active infection * Incompatibility to performing MRI examination.
Where it's running
-
Istituto Ortopedico Rizzoli
Bologna, Bo, Italy Recruiting
Study contacts
- Study coordinator: Giancarlo Facchini, Medicine and Surgery
- Email: giancarlo.facchini@ior.it
- Phone: +39 0516366836
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.