Treatment of Desmoid Fibromatosis With Arterial Embolization

NCT ID: NCT06945887

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-02-28

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.

Detailed Description

Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.The current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. Nonsurgical approaches remain suboptimal. For asymptomatic disease, current guidelines suggest an initial period of active surveillance. 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.

Doxorubicin is routinely used in the treatment of soft tissue sarcomas and other mesenchymal malignancies. Its use against desmoid fibromatosis is effective but associated with hematologic, gastrointestinal, and cardiac toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing, or life-threatening fibromatoses.

Conditions

Desmoid Fibromatosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Performed embolization

embolization therapy

Intervention Type: 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).

Interventions

embolization therapy

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).

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giancarlo Facchini, Medicine and Surgery

Role: CONTACT

giancarlo.facchini@ior.it

+39 0516366836

Facility Contacts

Giancarlo Facchini, Medicine and Surgery

Role: primary

giancarlo.facchini@ior.it

+39 0516366836

Other Identifiers

CE AVEC: 49/Oss/IOR

Identifier Type: -

Identifier Source: org_study_id