Treatment of Desmoid Fibromatosis With Arterial Embolization

NCT06945887 | Recruiting

• 1 other identifier: CE AVEC: 49/Oss/IOR
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Desmoid fibromatoses are rare and locally aggressive mesenchymal tumors. The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. These studies report promising results through the use of chemoembolization, that is, arterial embolization using particles loaded with chemotherapy. Instead, the type of treatment we propose would consist of injection of embolizing material without the use of chemotherapy, based on the positive results we have consistently reported over the years on arterial embolization of musculoskeletal tumors.

Conditions

Desmoid Fibromatosis

Keywords

Desmoid fibromatosis; Embolization

Outcome Measures

Primary Outcomes (3)

• Reduction of pain (VAS score)

  Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.

  1 year

• Reduction of antalgic therapy (mg)

  Mean reduction in the use of pain medications evaluated in mg of active ingredient taken daily before the treatment and at follow-up.

  1 year

• Volume reduction in cm³

  Reduction of the lesion evaluated with MRI, measuring the diameter of the lesion in cm³.

  1 year

Secondary Outcomes (2)

• Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)

  1 year

• Improvement in quality of life (EORTC QLQ - BM22)

  1 year

Study Arms (1)

Performed embolization

Procedure: embolization therapy

Interventions

embolization therapy PROCEDURE

Identification of the main vessels afferent to the tumor to be treated. -Selective and super-selective catheterization of pathological arterial branches, responsible for the blood supply to the neoplasm, through the use of micro-catheters. - Injection of embolizing material (hydrogel microspheres) - Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature).

Performed embolization

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by desmoid fibromatoses eligible to be treated with transarterial embolization

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Central Study Contacts

Giancarlo Facchini, Medicine and Surgery

CONTACT

+39 0516366836; giancarlo.facchini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)