Actively Recruiting
Treatment of Desmoid Fibromatosis With Arterial Embolization: Retrospective and Prospective Observational Study
Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-12
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Desmoid fibromatoses are rare, locally aggressive tumors affecting the connective tissue. This research investigates the use of arterial embolization without chemotherapy as a treatment option. Prior studies have shown promising results with chemoembolization, but this study focuses on embolization using particles alone, based on positive outcomes reported for musculoskeletal tumors. Surgery is often avoided due to high recurrence rates and increased tumor aggressiveness, making non-surgical options important to explore. The treatment involves identifying and catheterizing the arteries supplying the tumor, then injecting embolizing material called hydrogel microspheres to block blood flow to the tumor. This procedure is followed by imaging to confirm that over 90% of the abnormal blood vessels have been closed. The study includes patients who have already undergone embolization since January 2023 as well as new patients scheduled for this treatment. Participants will be monitored for up to one year to assess pain reduction, decreased use of pain medication, and tumor size reduction. Quality of life will also be evaluated using specialized questionnaires. The study involves clinical and imaging assessments, including MRI and CT scans, to track tumor activity and treatment effects. Safety measures exclude patients with certain infections, blood disorders, or those unable to undergo MRI scans.
CONDITIONS
Brief Title
Treatment of Desmoid Fibromatosis With Arterial Embolization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes aged 12 years and older
- Symptomatic and actively growing desmoid fibromatosis
- Not eligible for surgery or cryoablation
- Patients who have had embolization for desmoid fibromatosis since 01/01/2023 or are newly listed for this treatment
- Signed informed consent to participate in the study
You will not qualify if you...
- Life expectancy less than 3 months or severely impaired functional status (ASA 4)
- Desmoid fibromatosis not currently active as confirmed by clinical and imaging tests (MRI, CT)
- Blood clotting deficiencies or low platelet count disorders
- Active infections
- Unable to undergo MRI examination
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 procedure with follow-up assessments over 1 year
Participants undergo arterial embolization therapy involving injection of embolizing material to block blood supply to the tumor.
1 treatment visit and multiple follow-up visits over 1 year
Duration - 1 year
Participants are monitored over 1 year to assess pain reduction, medication use, tumor volume, and quality of life improvements.
Periodic visits during the year following treatment
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, BO, Italy, 40136
Actively Recruiting
Research Team
G
Giancarlo Facchini, Medicine and Surgery
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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