Actively Recruiting
Arterial Chemoembolization with Doxorubicin for Treating Symptomatic Desmoid Fibromatosis: A Prospective Observational Study
Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Desmoid fibromatoses are rare, locally aggressive tumors that arise from mesenchymal tissue. This research focuses on evaluating chemoembolization using Doxorubicin delivered through arterial embolization as a treatment for symptomatic and actively growing desmoid fibromatosis, especially in patients unsuitable for surgery or cryoablation. Current treatment guidelines favor active surveillance for asymptomatic cases and reserve chemotherapy for more severe presentations due to associated systemic risks. The study investigates chemoembolization, a procedure involving selective catheterization of arteries supplying the tumor and injecting hydrogel microspheres loaded with Doxorubicin. This approach aims to deliver high drug concentrations directly to the tumor site while minimizing systemic exposure. The procedure includes diagnostic arteriography to confirm successful embolization by occluding over 90% of the tumor's blood supply. Participants will be monitored over one year to assess outcomes such as tumor volume reduction, pain relief using VAS scores, and decreased need for pain medications. Quality of life improvements will also be evaluated using standardized questionnaires. Safety and procedural success will be tracked through imaging and clinical assessments throughout the study, with the total participation duration spanning one year.
CONDITIONS
Brief Title
Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic and actively growing desmoid fibromatosis confirmed by recent follow-up
- Patients who are not candidates for surgery or cryoablation
- Adults aged 18 years or older
You will not qualify if you...
- Life expectancy less than 3 months or severely impaired functional status (ASA 4)
- Desmoid fibromatosis not in active phase, confirmed clinically and by MRI or CT
- Blood clotting disorders or low platelet counts
- Active infections documented at the time of evaluation
- Patients younger than 18 years old (implied by minimum age criterion but stated here for clarity if applicable)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment event with follow-up assessments up to 1 year
Participants undergo arterial chemoembolization with doxorubicin to target desmoid fibromatosis through selective catheterization and embolization.
1 treatment visit (in-person) and multiple follow-up visits over 1 year
Duration - Up to 1 year
Participants are monitored for tumor volume reduction, pain relief, and quality of life improvements following treatment.
Periodic follow-up visits during 1-year post-treatment
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy, 40136
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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