Arterial embolization for desmoid fibromatosis
Treatment of Desmoid Fibromatosis With Arterial Embolization: Retrospective and Prospective Observational Study
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Drugs / interventions | chemotherapy, Doxorubicin |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06945887 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, BO
- Istituto Ortopedico Rizzoli — Bologna, Bo, Italy (Recruiting)
Study contacts
- Study coordinator: Giancarlo Facchini, Medicine and Surgery
- Email: giancarlo.facchini@ior.it
- Phone: +39 0516366836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.